Continuing Education Credit - Northeast Kentucky AHEC · 9/27/2017 6 16 TLC 2 – Provider Perspective • Before versus after • Staff and clinic engagement • Tools for discussion

9/27/2017

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Symposium

Lung CancerSmoking Cessation

&2nd Annual

SEPTEMBER 22, 2017Center for Health Education & Research

Morehead, KY

Continuing Education Credit

Successful CompletionFor successful completion of this continuing education program, participants must:

Sign appropriate attendance roster

Be present for the duration of the program

Complete the online evaluation within 7 days of they symposium. www.neahec.org/LCSeval (Authorization Code: 20170901)

NOTE: Nurses (CNE) and Certified Health Education Specialist (CHES) must complete and return a paper evaluation before leaving.

A statement of credit will be issued within two weeks following completion of all required documentation. For further information, please contact

KaSandra Hensley, Education Coordinator at kasandra.hensley@st-claire .

Reducing the lung cancer burden in Northeast Kentucky through an academic/community

partnership: A Terminate Lung Cancer (TLC) Study

Roberto Cardarelli, DO, MHA, MPH

Elizaneth Matera, MD

University of Kentucky

September 22, 2017

An Equal Opportunity University

An UPDATE…

9/27/2017

2


University of Kentucky

• Roberto Cardarelli, DO, MPH (Principal Investigator)

• Tony Weaver, MD

• Tom Tucker, PhD (Kentucky Cancer Registry)

• Karen Roper, PhD

• Brent Shelton, PhD (Markey Cancer Center)

St. Claire Regional Medical Center

• Gregory Bausch, PharmD (COO)

• Ashley Gibson, MS (Practice Facilitator/Coordinator)

• Kacie Bledsoe

Northeast AHEC

• David Gross

• Kasandra Hensley

Team


Aim 1. Disseminate lung cancer screening and tobacco cessation guideline education to an audience of inter-professional learners, including nursing students, physician assistant students, and medical students, family medicine trainees, and practicing providers in Northeast Kentucky.

Aim 2. Implement lung cancer screening and smoking cessation workflow processes within five ambulatory clinics affiliated with St. Claire Regional Medical Center (SCRMC) using implementation science principles and process/quality improvement methods.

Aims


Study Region

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Methods

• Aim 1: Dissemination– Interprofessional - learner spectrum

• Practicing primary care providers

• Family Medicine residency (2)

• Medical students

• Nursing students

• PA students

7


Methods

• Aim 1: Dissemination– Academic detailing in SCRMC clinic

system

– Lung cancer regional symposium and a community educational event

– Didactics

– Interprofessional case series

– SCRMC Research Day

8


Methods

• Aim 2: Implementation– PF will guide:

• performance evaluation and feedback

• clinician and staff training in quality improvement methods

• coordination of quality improvement initiatives

• disseminating best practices

• team building and other skills necessary to carrying out the study’s activities

9

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Preliminary Outcomes

• Aim 1: Dissemination– Our reach:

• 2016 Symposium – 81 attendees

• SCR Research Day (16/17) – 90 attendees

• Academic detailing (3 clinics) – 22 staff/providers

• Medical/Nursing/PA students/FM residents – 160

– Summary impact: Improvements in LCS and TC beliefs across learners -

10


Preliminary Outcomes

• Aim 2: Implementation– On our 3rd clinic

– Initial 2 clinics• Increasing trend in % LDCT ordered in last 12

months and TC education documentation (Clinic 1)

11

0%

3.8

0%

11

.30

%

BASEL IN E W ED G E 1 W ED G E 2

CLINIC 1- %SMOKING CESSATION DOCUMENTATION

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5

1.1

0%

2.3

0%

8.3

0%


CLINIC 1- %LDCT ORDERED IN LAST 12 MONTHS1

.70

%

11

.60

%

11

.70

%


CLINIC 2- % SMOKING CESSATION DOCUMENTATION

0.00%

2.00%

4.00%

6.00%

8.00%

10.00%

12.00%

Baseline Wedge 1 Wedge 2

CLINIC 2 - %LDCT ORDERED IN LAST 12 MONTHS

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16

TLC 2 – Provider Perspective• Before versus after• Staff and clinic engagement• Tools for discussion with patients• Health maintenance item added to track compliance• Sustainability – what drives continued improvement?• Data: continual feedback on how we’re doing• Improvement in processes: is the initial method

working? What additional process could we add? What works for other preventive care tasks?• EHR as driver: how can we get the EHR to help with reminders when, for example, it does not track pack years?


Thank you.

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Lung Cancer Treatment UpdatesVal R. Adams, Pharm.D., FCCP, BCOP

Associate Professor

Univeristy of Kentucky, Markey Cancer Center

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Objectives

• Differentiate the mechanism of action for recently approved lung cancer therapies.

• Recall the role in therapy of current and emerging targeted therapies for the treatment of metastatic non‐small cell lung cancer.

• Recognize the response rate and expected time to respond for the new immunotherapy.

• Identify strategies to prevent and manage adverse events related to the new therapies.

Spread of lung cancer disease at diagnosis and corresponding 5 year survival in the United States (SEER Database https://seer.cancer.gov/statfacts/html/lungb.html accessed 8/14/2017)

The Increasing Complexity if Making Tx Decisions

Lung Cancer

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Targetable Mutations

Kohno, T. et al. Translational Lung Cancer Research. 2015; 4:156‐64

CTL - tumor cell interactions

Avoiding Immune Surveillance

IFN = interferon; IL = interleukin; TNF = tumor necrosis factor.

Schreiber et al. Science. 2011;331:1565‐1570. For educational purposes only.

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Checkpoint Inhibitors for NSCLC

Advanced NSCLC

PD‐L1 +pembrolizumab

Targeted Therapy or Chemotherapy

After failing chemotherapy• Nivolumab or • Pembrolizumab or• Atezolizumab

Essentially, all lung cancer patients will get immunotherapy in the first or second line setting (except EGFR or ALK + patients).

NSCLC = non‐small cell lung cancer.

NonsquamousPembrolizumab +Chemotherapy

~30% ~40%

~ 30%

First Line Pembrolizumab

Pembrolizumab 200 mg IV every 3 weeks x 35 cycles

Investigator’s choice of cytotoxic chemotherapy x 4–6

cycles

Carboplatin + pemetrexed*

Cisplatin + pemetrexed*

Carboplatin + gemcitabine

Cisplatin + gemcitabine

Carboplatin + paclitaxel*Pemetrexed only for nonsquamous tumors; can continue pemetrexed as maintenance after combination therapy.

International, randomized, open-label, phase III trial

IV = intravenously.

Reck, M., et al. N Engl J Med 2016;375:1823‐33

Median:Pembrolizumab10.4 months (95% CI 6.7–not reached)Chemotherapy6 months (95% CI 4.2–6.2)

PFS

Results from Keynote 24

OS

Estimated % patients alive at 6 months:Pembrolizumab80.2% (95% CI 72.9–85.7)Chemotherapy72.4% (95% CI 64.5–78.9)

Reck, M

., et al. N EnglJ Med 2016;375:1823‐33

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Trial Design and Treatment

*Investigators could determine to continue pemetrexed as maintenance after combination therapy –maximum duration of pembrolizumab = 24 months.

Randomized, open-label, phase II trial in the US and Taiwan

Carboplatin/pemetrexed/ pembrolizumabQ21d x 4 cyclesMaintenance:* Pembrolizumab N = 60

Carboplatin/pemetrexed Every 21 days x 4 cyclesMaintenance:*

N = 63

Pembrolizumab [package insert]. Whitehouse Station, NJ: Merck & Co Inc; 2017.

Outcomes: ORR, PFS, OS

First‐Line Treatment:

Advanced‐stage NSCLC

stratified for PD‐L1 TPS (<1%)

Results

Patients on chemotherapy offered pembrolizumab monotherapy upon progression

Pembrolizumab [package insert]. Whitehouse Station, NJ: Merck & Co Inc; 2017.

Lung Cancer: Second‐line Check Point Inhibitor

Borghaei H, , et al. N Eng J Med 2015;373:1627‐1639. Brahmer J, et al. N Eng J Med ;2015;373(2):123‐135. Rittmeyer A, et al. Lancet. 2017;389:255‐265. Herbst RS, et al. Lancet. 2016;387(10027):1540‐1550..

Drug (study) Comparisons PFS Overall Survival

Atezolizumab

(OAK)

Atezolizumab 1200 mg IV q3week

vs.

Docetaxel 75 mg/m2 IV q3week

Median 2.8 months vs.

4 months

Median 13.8 months

vs. 9.6 months

(p = 0.0003)

Nivolumab

(CheckMate 017)

Squamous Histology

Nivolumab 3mg/kg IV q2week

vs.



2.8 months


6.0 months

(p < 0.001)

Nivolumab

(CheckMate 057)

Non‐Squamous

Nivolumab 3mg/kg IV q2week

vs.



4.2 months

Median 12.2months

vs. 9.4 months

(p =0.002)

Pembrolizumab

(KEYNOTE‐010)

Pembrolizumab 2 mg/kg IV q3week

vs.



4 months

Median 10.4months

vs. 8.5 months

(p = 0.0008)

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Recent Update PACIFIC Trial

Durvalumab after chemoradiotherapy Stage III

Antonia, SJ, et al. N Engl J Med. epub Sept 8, 2017

Patterns of Response to PembrolizumabObserved in Advanced Melanoma

Hodi, FS, et al. J Clin Oncol 2016;34:1510‐7.

RECISTUnidimensional Measurement

irRECISTBidimensional Measurement

CR Disappearance of all lesions

PR≥ 30% decrease in tumor burden compared with baseline†

≥50% decrease in tumor burden compared with baseline†

SD Not PR, CR, or PD

PD

≥ 20% + 5-mm absolute increase in tumor burden comparedwith nadirAppearance of new lesions or progression of nontarget lesions

≥ 25% increase in tumor burden compared with baseline,nadir, or reset baseline†New lesions added to tumor burden†

irRECIST

CR = complete response; PD = progressive disease; PR = partial response; SD = stable disease

Hodi, FS, et al. J Clin Oncol 2016;34:1510‐7.

† Confirmation Required – next scan ≥ 4 weeks later

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Immune‐Related Adverse Events by System

Pulmonary: Pneumonitis, respiratory failure

Endocrine: Thyroiditis, hypothyroidism, hyperthyroidism, hypophysitis, hypopituitarism, adrenal insufficiency

Cardiac: Pericarditis, myocarditis, vasculitis

GI: Nausea, colitis, perforation, pancreatitis

Heme: Red cell aplasia, pancytopenia, autoimmune neutropenia

Ocular: Uveitis, iritis, conjunctivitis, scleritis, blepharitis

Skin: Vitiligo, pruritus, rash, lichenoid deposits

Liver: Transaminitis, hepatitis

Kidney: Nephritis, renal insufficiency

Musculoskeletal: Arthralgias, myalgias

Neurologic: Neuropathy, meningitis, Guillain‐Barré syndrome, myasthenia gravis, temporal arteritis

Immunotherapy‐Related AEs

• Median time to onset for treatment‐related select AEs ranged from 5.0 weeks for skin AEs to 15.1 weeks for renal AEs.

• Circles represent median; bars signify ranges.

Time to Onset of Select Treatment-Related AEs

(any grade; N = 474)

AE = adverse event.Wolchok J, et al. J Clin Oncol. 2015;33:abstract LBA1.

POPLAR: All‐Cause AEs (≥5% diff. between arms)

• AE profiles consistent with previous studies

• For atezolizumab, other immune‐mediated AEs (any grade) included:

• AST increased (4%)

• ALT increased (4%)

• Pneumonitis (2%)

• Colitis (1%)

• Hepatitis (1%)

ALT = alanine aminotransferase; AST = aspartate aminotransferase. Spira et al. J Clin Oncol. 2015;33:abstract 8010.

Dry skin, stomatitis, and nail disorder were additional AEs with ≥5% higher frequency with docetaxel. Safety population includes patients who received any amount of either study treatment. Data cut-off January 30, 2015

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Immune‐Related Adverse Events

• Assume new symptoms are autoimmune and drug related if all other causes have been ruled out

• Can affect any organ system

• Early recognition, evaluation, and treatment are critical to adequate management and opportunity for re‐treatment.

Management of Immune‐Related AEs Algorithm

Management dose represents steroid doseGrade 2 is prednisoneGrade 3/4 toxicity is IV methylprednisoloneHRT = Hormone Replacement Therapy

Eigentler, TK, et al. Ca Treat Rev 2016;45:7‐18

Precision Medicine/Targeted Therapy

Lung Cancer

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Patient CaseSJ is a 61 yo WF who presents with NSCLC

HPI: After failing antibiotics a CXR revealed a left lower lobemass – FNA confirmed adenocarcinoma of the lung

PMH: N/A

FH/SH: Married w/ two sons 28 and 34 (none smoker)

Drug History: NKDA

PE: Findings consistent with lung cancer – otherwise WNL (PS 0‐1)

Labs: Hepatic, renal, and chemistry levels WNL

Radiology: Multiple lesions in the liver– stage IV

Genetics: KRas – WT, EGFR exon 19 deletion, no ALKrearrangement, no ROS1 rearrangement, PD‐L1 unknown

What Treatment would you recommend?

1. None

2. Pembrolizumab

3. Carboplatin –paclitaxel – Bev

4. Erlotinib

5. Crizotinib

OPTIMAL = Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive NSCLC; G/C = Gemcitabine/Carboplatin.Zhou C, et al. Lancet Oncol. 2011;12(8):735-742.

OPTIMAL: First‐line Erlotinib is Associated with Longer PFS vs G/C in EGFR Mutant NSCLC

Time (months)

Pro

gre

ssio

n-f

ree

surv

ival

(%

)

100

60

40

20

0

80

0 5 10 15 20

Erlotinib (N=82)Gemcitabine plus carboplatin (N=72)

HR 0.16 (95% CI 0.10 – 0.26)Log-rank p<0.0001

Number at riskErlotinib 82 70 51 20 2

72 26 4 0 0Gemcitabine pluscarboplatin

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First Line EGFR TKI

Agents N Outcome1 Outcome2 Comment

Gefitinib vs Carbo‐Tax

1217 1 yr PFS 25% vs 7%

Median OS19 mo vs 17 mo

IPASS trial

Erlotinib vs platinum doublet

228 Median PFS10 mo vs 5 mo


EURTAC trial

Afatinib vs Cisplatin‐Pem

1269 Median PFS11 mo vs 7 mo


Lung‐LUX3

CHI, A, et al Biomarker Research 2013;1:1‐10, Yang, JC, et al. Lancet Oncol2015;16:141‐51

• Better than Chemo first line based on PFS, OS roughly equivalent likely due to cross‐over.

• Survival curves do not plateau – Resistance develops during treatment.

Resistance to EGFR TKIs

Nguyen, K.H., Kobayashi, S., Costa,k D.B., Clin Lung Cancer 2009;10:281‐9

Comparison to Chemotherapy: AURA3

• Stratification variables• Asian vs non‐Asian

Mok, TS, et al. N Engl J Med 2017;376:629-40

Osimertinib 80 mgPO DailyN=279

Cisplatin or carboplatin +Pemetrexed

repeat every 3 weeks up to 6 cycles – maintenance pemetrexed allowed

N=140

Eligibility:Progression on 1st line EGFR TKIT790M mutationStable CNS metastases w/o steroids

Primary Endpoint – PFSSecondary Endpoints include – ORR, DoR, OS, Safety

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Osimertinib vs Chemotherapy: AURA3

Mok, TS, et al. N Engl J Med 2017;376:629-40

First line Osimertinib: FLAURA

ESMO 2017 Congress: Abstract LBA2. Presented September 8, 2017

Osimertinib 80 mgPO DailyN=279

Gefitinib 250 mg PO daily orErlotinib 150 mg PO daily

N=277

Eligibility:Advanced Stage NSCLCEGFR activating mutation (Exon 19d or L858R mutation)

Primary Endpoint – PFSSecondary Endpoints include – ORR, DoR, OS, Safety

FLUARA Results


Months

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FLUARA Results


Percentage

EGFR + Advanced Disease Summary

Osimertinib monotherapy or 2 sequential oral EGFR TKIs provide a median of 19 ‐ 20 months of disease free survival. Overall survival yet to be determined – With chemotherapy and immunotherapy Median OS could be 3‐4 years

PFS = 10 MonthsPFS = 10 months

PFS = 19 months

ALEX: New Standard is Coming for ALK+

• Primary endpoint – PFS

• Secondary endpoints– ORR– OS– Time to CNS progression– Safety

Treatment Naïve ALK+

Advanced DzStratified for PS 0 or 1 vs 2

Asian vs Non‐AsianCNS mets

1:1

Alectinib600mg PO twice dailyn = 152

Crizotinib 250 mg PO twice daily

n = 151

Peters, S. et al. N Engl J Med 2017;377:829‐38

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Alex Results


Median PFSAlectinib = 25.7 monthsCrizotinib = 10.4 months

ORRAlectinib = 82.9%Crizotinib = 75.5%

CNS complete responseAlectinib = 38%Crizotinib = 5%

ALEX Results


Alectinib Toxicity

Grade ¾ differences of 5% or moreTransaminases Crizotinib > Alectinib


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ALK+ Summary of PFS

Chemo PFS = 7 months

Crizotinib PFS = 10 months

Ceritinib PFS = 17 months

Alectinib PFS = 25.7 months

Toxicity – Chemotherapy similar to crizotinib‐ Chemotherapy slightly less than ceritinib‐ Crizotinib more toxic that alectinib

Crizotinib Remains the Standarde for ROS1+

• ORR = 72%• 6% CR

• 66% PR

• Duration of Response = 17.6 months

• 7 ROS1 fusion partners

• Toxicity consistent with prior experience

PFS = 19 months

Shaw, A., et al. N Engl J Med 2014;371:1963‐71

Dabrafenib/Trametinib for BRAF+

• Single Arm Phase II trial (n=57)• 1 prior tx 66%

• 2 or 3 prior txs 33%

• Adenocarcinoma 98%

• Smoking History• Never Smoker (28%), Former smoker (61%)

• Endpoints• PFS

• ORR

• DoR

Planchard, D., et al Lancet Oncol 2016;17:984‐93

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PFS


Median 9.7 months

Response


All Cause Toxicity Grade 3/4

Toxicity % Toxicity %

Asthenia 4% Respiratory Dist 4%

Anemia 6% Neutropenia 9%

Hypertension 4% Hemorrhage 4%

Dehydration 4% Hypercalcemia 4%

Hyponatremia 7% AST/GGT 4%

Leukopenia 4% Sq. Skin Cancer 4%


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Efficacy Changes Summary

• Platinum Doublet PFS = 3.7 mo OS = 8 mo

• PD‐L1+ disease in ~ 30% of advanced stage patients• PFS with Pembrolizumab 10 months (first line monotherapy)

• Targetable Driver Mutation in ~ 20%

• PFS w/ targetable mutational drivers• EGFR 19‐20 months (first line)

• ALK 25‐26 months (first line)

• ROS1 19 months (first line)

• BRAF 10 months (2nd line)

Schiller, JH, et.al. N Engl J Med 2002;346:92‐8 Peters, S. et al. N Engl J Med 2017;377:829‐38Shaw, A., et al. N Engl J Med 2014;371:1963‐71 Planchard, D., et al Lancet Oncol 2016;17:984‐93Reck, M., et al. N Engl J Med 2016;375:1823‐33 ESMO 2017 Congress: Abstract LBA2. Presented September 8, 2017

The Best Science Requires Implementation

Make Sure Patients Get Tested!!!

Percent of Patients w/Lung Cancer Not Tested in 2016

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BreakWe will resume at 10:50 AM.

Time for

Lung Cancer Survivorship and Tobacco Treatment

Jamie L. Studts, PhDProfessorDepartment of Behavioral ScienceUniversity of Kentucky College of Medicine

Assistant DirectorCancer Prevention and Control

Lucille P. Markey Cancer Center

JAMA. 2017;317(4):388-406.

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Lung Cancer Incidence in Kentucky

Cancer Survivorship Trends in US

Bluethmann SM, Mariotto AB, Rowland, JH. Anticipating the ''Silver Tsunami'': Prevalence Trajectories and Comorbidity Burden among Older Cancer Survivors in the United States. Cancer Epidemiol Biomarkers Prev. 2016;25:1029-1036.

Cancer Survivorship in the US (by site)

Miller, K. D., Siegel, R. L., Lin, C. C., Mariotto, A. B., Kramer, J. L., Rowland, J. H., Stein, K. D., Alteri, R. and Jemal, A. (2016), Cancer treatment and survivorship statistics, 2016. CA: A Cancer Journal for Clinicians.

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There have been exciting and optimism-inducing innovations in lung cancer care.

Minimally Invasive Surgical Procedures (VATS)

Stereotactic Body Radiation Therapy (SBRT)

Targeted Therapies & Immunotherapies

Survivorship and Palliative Care Innovations (Temel Study)

Targeted Lung Cancer Screening (NLST)

Additive Tobacco Treatment Strategies

The Commonwealth’s Cancer

Objectives

1) Describe the lung cancer survivorship burden within the region.

2) Discuss and gain an appreciation for innovative ongoing research in lung cancer survivorship.

3) Explain the role of evidence-based tobacco treatment in lung cancer survivorship care.

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Lung Cancer Survivorship

How would we describe the experience of anindividual diagnosed with lung cancer?

How would we like to describe the experience of an individual diagnosed with lung cancer?

Individuals diagnosed with lung cancer commonly experience substantial psychosocial burden.

Zabora, J., Brintzenhofeszoc, K., Curbow, B., Hooker, C., & Piantadosi, S. (2001). The prevalence of psychological distress by cancer site. Psycho-Oncology, 10, 19-28.

The physical symptom burden of lung cancer is similarly substantial due to several disease and treatment factors.

Sleep

Fatigue

Distress Dyspnea

Pain

(Pratt Pozo et al., (2014). Cancer Control, 21, 40-50)(Sanders et al., (2010). Psycho-Oncology, 19, 480–489)(Sugimura & Yang (2006). Chest, 129, 1088-1097)(Vijayvergia et al., (2015). JNCCN, 13, 1151-1161)

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Social support holds a vital, but complex role in lung cancer survivors.

Social SupportSocial support was associated with multiple quality of life components

Social support from clinicians was associated with physical and emotional QoL

Social support from family/friends was associated with emotional QoLLuszczynska, et al., (2013). Psycho-Oncology, 22(10), 2160–2168.

Social ConstraintsIndividuals diagnosed with lung cancer and their spouses reported a wide variety of social constraints, including denial, avoidance, and conflict that can hinder open spousal communication.

Specifically, patients and spouses reported trouble discussing continued tobacco use, cancer-related symptoms, prognosis, and the emotional effects of lung cancer on the spouse.

Badr & Carmack Taylor (2006). Psycho-Oncology, 15(8), 673–683.

Individuals diagnosed with lung cancer face substantial stigma and bias.Perceived Stigma Recognition of negative appraisal and devaluation from

others

Enacted Stigma (Bias) Overt acts of discrimination from others

Internalized Stigma (Self-Blame) Belief that negative attributions are true and deserved

Constrained Disclosure Reduced willingness to discuss diagnosis, restricted

support option

Hamann, H. A., Ostroff, J. S., Marks, E. G., Gerber, D. E., Schiller, J. H., & Lee, S. C. (2014). Stigma among patients with lung cancer: a patient-reported measurement model. Psycho-Oncology, 23(1), 81-92. doi:10.1002/pon.3371

Individuals diagnosed with lung cancer demonstrate a range of risky behaviors.

• Systematic review of studies addressing tobacco use following diagnosis of lung or head/neck cancer.

• Approximately 1/3 of all individuals with lung or head/neck cancer continue to use tobacco.

• Over half of individuals who use tobacco at baseline continue to use

Burris JL, Studts JL, DeRosa AP, Ostroff JS. Cancer Epidemiol Biomarkers Prev. 2015;24(10):1450-1461.

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Rural-residing lung cancer survivors experience additional challenges.

Rural LuCa survivors report poorer mental health relative to Urban LuCa survivors.

Some evidence suggests poorer access and less use of mental health services and cancer support groups among rural survivors.

(Andrykowski et al., 2014) (Andrykowski & Burris, 2010)

Lung cancer survivors are less likely to be engaged and actively involved in care.

Few individuals diagnosed with early stage lung cancer experience shared decision making.

Hopmans, et al. (2015). BMC Cancer, 15(1), 959.

Noteworthy discordance in perceptions of decision making between individuals diagnosed with lung cancer and clinicians.

Hotta, et al. (2010). Journal of Thoracic Oncology, 5(10), 1668–1672.

Over two-thirds of individuals receiving chemotherapy for metastatic lung cancer did not understand that their treatment would not being delivered with curative intent.

Weeks, et al. (2012). New England Journal of Medicine, 367(17), 1616–1625.

Efforts to encourage engagement and activation have been recently initiated but have yet to increase patient activation.

Groen, et al. (2016). Journal of Clinical Oncology, 34(3_suppl), 201.

Patie

nt E

ngag

emen

t

In summary, how should we think about lung cancer survivors in Kentucky?

Lung Cancer Survivors are likely to experience:

1) …clinically-relevant levels of distress

2) …prominent symptom burden

3) …multiple health-compromising behaviors

4) …substantial stigma as well as self-blame

5) …lower levels of social support (complicated)

6) …substantially less engagement and motivation for care

7) …barriers to access care, survivorship care, in particular

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Precision Medicinean emerging approach

for disease treatment and prevention that takes into

account individual variability in genes, environment, and

lifestyle for each person.

How might precision medicine/oncology apply to patient-centered care, including survivorship care? Patient

Preferences

Values

BeliefsOpinion

Precision Survivorship Care The Kentucky LEADS Collaborative Lung

Cancer Survivorship Care Program is a Precision Medicine approach to Survivorship.

By design, the intervention targets the most prevalent and distress symptoms and challenges associated with a lung cancer diagnosis.

By integrating patient preferences, the intervention is tailored to the unique needs of the survivor, the preferred delivery method, and the desired level of involvement of the social support network.

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The Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program

Survivorship Care (SC) Patient and Caregiver Intervention

Built and implementing a novel psychosocial survivorship care intervention for individuals diagnosed with lung cancer and their caregivers (10 sites, 300 participants)

Four key domainsLung cancer info

Symptom coping

Psychosocial concerns

Caregiver support LEADS

KENTUCKY

COLLABORATIVE

Psychosocial Concerns

Symptom Coping

Caregiver Support

Lung Cancer

Info

Patient Modules (Session Topics)1) Lung Cancer Basics

2) Navigating the Healthcare System

3) Coping with Pain/Addiction Concerns

4) Coping with Fatigue

5) Coping with Sleep Problems

6) Coping with Shortness of Breath

7) Coping with Distress

8) Social Support

9) Values and Decision Making

10) Healthy Living

11) Tobacco Use

12) Caregiver Concerns and Self-Care

Lung Cancer Info (2)

Symptom Coping (4)

Psychosocial Concerns (5)

Caregiver Support (1)

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Survivorship Care (SC)Specialist Training Program

A sustainable companion training program to support KY LEADS SC Specialists in their work with the program.

Training ProgramOnline CE Program

Training Manual

Survivor/Caregiver Workbook

Online CEIntervention

Training

TrainingManual

In-Person Module

Training

LearningCommunity

SC Specialist Treatment Manual & Survivor Workbook

428 “spell-binding” pages 270 “riveting pages”

Tobacco Treatment following a

Lung Cancer Diagnosis

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Callously talking about tobacco can contribute to

stigma

Callously talking about tobacco can contribute to

stigma

Lop-sided and brief

discussions can harm

relationships

Lop-sided and brief

discussions can harm

relationships

Empathic consultations can

improve relationships and health outcomes

Empathic consultations can

improve relationships and health outcomes

Evidence-based interventions are

available and improving

Evidence-based interventions are

available and improving

Benefits of Tobacco Cessation following a Cancer Diagnosis

Reduced symptom burden

Reduced chance of 2nd cancer

Increased treatment efficacy

Reduced mortality

Improved quality of life

Serve as role model

Treating Tobacco Use & Dependence: The 5 A’s

1. Ask about tobacco use

2. Advise to quit

3. Assess willingness to quit

4. Assist in quit attempt

5. Arrange follow-up

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ASCO Tobacco Cessation

Guidelines1) Talking to Patients about

Tobacco Use

2) Motivating Patients to Stop Using Tobacco

3) Treating Nicotine Dependence in Patients with Cancer

4) Incorporating Tobacco Dependence Treatment into Your Practice

© 2012 American Society of Clinical Oncology.

National Comprehensive Cancer NetworkSmoking Cessation Guidelines

General Principle• “There are health benefits to smoking

cessation even after a cancer diagnosis, regardless of stage or prognosis….”

Clinical Recommendations1) Combining pharmacologic therapy and

behavioral there is the most effective approach.

2) Smoking status should be documented in the health record.

3) Smoking relapse and brief slips are common.

4) Smoking cessation should be offered as part of oncology treatment, and continued throughout the entire care continuum.

Tobacco Use Treatment (TUT) Services at NCI-Designated Cancer Centers

(Goldstein, Ripley-Moffitt, Pathman & Patsakham (2013). Tobacco use treatment at the U.S. National Cancer Institute’s Designated Cancer Centers. Nicotine & Tobacco Research, 15, 52-58.)

62

53

48

TUT PROGRAM ACTIVITIES

Routine TUT Materials

Identified TU

TUT Employee

• Suboptimal implementation of evidence-based tobacco use treatment in NCI-designated centers.

• Recommend establishing standards and funding to support TUT in oncology.

• Needs include stable funding, trained personnel (CTTSs), and space.

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Markey CARES Tobacco Program

Markey

Cancer

Assessment,

Referral,

Engagement, and

Support

Tobacco Program

MCC Outpatient Visit

Screen for tobacco use

Document baseline tobacco use status in

EHR

Enrollment in TelASK Quit Manager

Former tobacco useror

Never tobacco useror

Unknown tobacco user status

1 2 3

Tailored support and follow-up in clinic

MCC TTS mails “Recommendation and Referral” postcard

Patient unreachablevia phone or in clinic

Patient opts out of treatment

Document 6-month tobacco use status in EHR

EHR = Electronic health recordMCC = Markey Cancer Center

TTS = Tobacco treatment specialist

Markey CARES Tobacco Program

Current tobacco user(3 actions occur)

Automated support and follow-up via

phone

Patient engages in treatment

Referral to MCCPsych-Oncology TTS

(Dr. Jessica Burris, Principal Investigator)University of Kentucky Markey Cancer Center

Penn Tobacco Cessation TrialIndividual Cognitive-Behavioral Therapy

Comparison of CBT with GHE (General Health Education)

1 individual session & 2 telephone sessions

109 individuals with cancer (Lung & H&N)

All received nicotine replacement therapy (NRT)

Outcome: 30-day point prevalence

No Difference @ 1 month: CBT 45% vs. GHE 47%

No Difference @ 3 months: CBT 43% vs. GHE 39%

Both are above standard estimates of cessation

(Schnoll et al., 2005)

The Dynamics of Smoking Cessation After Cancer Diagnosis: A Naturalistic Study

“CATS: Cancer Adjustment and Tobacco Study”

Funding source: K07 CA181351 Dr. Jessica Burris (PI)

Overarching goal is to unpack the “black box” of cancer diagnosis as a teachable moment for smoking cessation• Population: Head/neck and cervical cancer patients who are current

smokers at time of cancer diagnosis• Approach: Intensive longitudinal study with technology-facilitated data

collection• Innovation: remote, daily assessment of behavior change processes

Specific Aims1) Describe key events in the process of smoking cessation, including

quit attempts, lapses, and relapses2) Uncover cognitive and affective variables that promote or undermine

the process of smoking cessation

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The Dynamics of Smoking Cessation After Cancer Diagnosis: A Naturalistic Study

Cancer Adjustment and Tobacco Study (CATS)

Funding source: K07 CA181351 Dr. Jessica Burris (PI)

Optimization of Smoking Cessation Strategies in Community Cancer Programs for Newly Diagnosed

Lung and Head and Neck Cancer Patients

Kentucky Cancer Survivors are UniqueMore individuals continue to smoke/use tobacco following diagnosis

The culture of tobacco creates additional socioecological barriers to cessation

Limited access to intensive cessation resources

Study AimsTo identify an efficacious, implementable cessation strategy for lung and head and neck cancer patients undergoing cancer therapy in Kentucky cancer centers.

To assess the feasibility of routinely implementing an array of smoking cessation strategies for this population.

To deliver high quality smoking cessation to all subjects.

Funding source: KY Lung Cancer Research Foundation Drs. Joe Valentino & Jamie L. Studts (PIs)

Optimization of Smoking Cessation Strategies in Community Cancer Programs for Newly Diagnosed

Lung and Head and Neck Cancer Patients

Study Schema

Enrolled over 70 participants across Kentucky.

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Smoking Cessation Treatment Delivery to Cancer Survivors with Low Social Resources

Funding source: KY Lung Cancer Research Foundation Dr. Jessica Burris (PI)

• Overarching goal is to facilitate cancer survivors’ use of free and low-cost resources that could address key social challenges that might otherwise undermine quit success

• Specific Aims1) Evaluate feasibility and

acceptability of a new approach to smoking cessation treatment in cervical cancer survivors with low social resources

2) Assess treatment efficacy for key events in the process of smoking cessation

Summary and Conclusions

Individuals diagnosed with lung cancer are likely to experience substantial symptom burden, but are less likely to seek supportive care.

Supportive care options that are specifically relevant to lung cancer survivors are emerging.

The burden of tobacco following diagnosis of lung cancer can exacerbate symptoms and compromise outcomes of treatment.

It is vitally important to intervene and assist with evidence-based tobacco treatment efforts among lung cancer survivors.

New research is contributing to efforts to improve our approaches to tobacco treatment among cancer survivors.

Vigilance and a liberal distribution of empathy, compassion, and support are vital to improving all lung cancer outcomes.

Karen M. Butler, DNP, RN, &

Ellen J. Hahn, PhD, RN, FAAN

BREATHE

University of Kentucky College of Nursing

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BREATHE: Who We Are

Our Mission: Our Vision:

To promote lung health and healthy environments to achieve health equity through research; community outreach and empowerment;

advocacy and policy development; and

access to health services.

All people will have access to clean air and live in healthy environments.

Overview of Today’s Presentation

Part One

Synergistic risk:

How to combine radon and tobacco smoke messages to prevent

lung cancer.

Part Two

Research demonstrating impact of FRESH on

synergistic risk perception among

homeowners.

Lung Cancer, Age Adjusted Mortality Rates by State, 2013

Data Source: CDCtp://

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Background: Lung Cancer

Tobacco Smoke 85% lung cancer cases caused by tobacco smoke.

3,000 lung cancer deaths per year among nonsmokers from secondhand smoke.

Radon 20,000 lung cancer deaths per year from radon exposure (only 2,100‐2,900 among never smokers).

Of those exposed to at least 4 pCi/L of radon, the risk of developing lung cancer is estimated at 62/1,000 for smokers and 7/1,000 for nonsmokers.

Most never smokers with lung cancer are women.

Part One:Combining Radon and Tobacco Smoke

Messages to Prevent Lung Cancer

Purpose: To describe innovative approaches to communicating the combined risk of exposure to both radon and tobacco smoke to the public.

This synergistic risk dramatically increases the likelihood of lung cancer.

Health care and radon professionals, environmental health practitioners, and tobacco control advocates are in a unique position to work together to prevent lung cancer.

What is Radon? Odorless, colorless, tasteless gas

Soil gas infiltration primary source of indoor radon exposure.

Becomes a problem when it gets trapped inside homes or other buildings

While 60% have heard of radon, few have tested for radon.

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Radon in Kentucky

Radon Testing

• 1 in 15 U.S. homes have radon at or above 4pCi/L

•Short‐ and long‐term radon test kits

Radon and Lung Cancer

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Factors that Contribute to Risk of Radon‐induced Lung Cancer

• Level of exposure

• Duration of

exposure

• Exposure to tobacco

smoke

Secondhand Smoke and Lung Cancer

Nonsmokers exposed to secondhand smoke at home or work increase their risk of developing lung cancer by 20 to 30 percent.

Nearly half of all nonsmoking Americans are still regularly exposed to secondhand smoke.

Why is Secondhand Tobacco Smoke so Toxic?

Methanol

Carbon Monoxide

Hydrogen Cyanide

Acetone

Tar

DDT

Naphthalene

Vinyl Chloride

Benzene

There is no risk‐free level of exposure to firsthand or secondhand tobacco smoke

SHS contains at least 7,000 chemicals. At least 69 are known to cause cancer in humans.

• Formaldehyde

• Mercury

• Lead

• Arsenic

• Toluene

• Cadmium

• Ammonia

• Butane

• Ethanol

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Eliminating SHS in the Home

Ask household members to sign a smoke‐free pledge.

Post a no smoking sign as you enter the home.

Ask smokers to smoke outside, wear a smoking jacket to cover clothes, and leave jacket outside.

Smoke outside at least 20 feet from doors, windows, and vents.

Move ashtrays out of the house and away from doors, windows, vents.

Eliminating SHS in the Home

Personalize relevance.

Explore perceived risk for health problems and lung cancer worry.

Enlist social support.

Discuss benefits and barriers.

May be a benefit when trying to sell home.

SHS may cause radon levels to be artificially low.

May encourage smokers to want to try to quit.

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Create a Teachable Moment!

Adapted from the Teachable Moment model (McBride et al., 2003)

Secondhand Smoke and Radon: A Dangerous Combination!

Secondhand smoke particles linger in the air and are small enough to be inhaled directly into the lungs.

Radon byproducts have a static charge and are attracted to secondhand smoke particles in the air.

The combination of radon attached to secondhand smoke particles greatly increases the likelihood of lung cancer.

Framing Synergistic Risk

Breathing radon is dangerous, but it is more harmful when you also breathe tobacco smoke (or have exposure to tobacco smoke in your lifetime).

People who are not exposed to tobacco smoke can still get radon‐induced lung cancer.

There are no safe levels of either radon or secondhand smoke.

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Personalized Messaging Make the opportunity to incorporate personalized messages into everyday face‐to‐face individual and group interactions. Ask about tobacco use, SHS exposure, and radon testing.

Conversation opens the door for education about why and how to test and fix the home for radon, and why and how to establish a smoke‐free home policy.

Printed Materials

Targeted, colorful brochures and posters can be placed in high traffic areas such as community centers, grocery stores, post offices, and medical offices.

Push cards can be used in church bulletins.

School Programs and Mailings

Use educational materials in school and programs and mailings targeting child health.

Programming in conjunction with National Radon Action Month can increase awareness about the synergistic risks and solutions.

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Community Events

Community awareness events

Community meetings

Health fairs

Social events

Farmers’ markets

Church events

Media Campaigns Target messages about the dangers of radon and tobacco smoke via mass media channels:

Ads (print and radio)

Op‐eds

Busboards

Earned Media

Social media

Target populations who are at high risk for tobacco use such as lower socioeconomic groups.

Earned Media

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Social Media Facebook

Twitter

Instagram

Can reach large populations who are more in tune with electronic communication.

Culturally Sensitive Messaging:Listen to Your Community!

Culturally Sensitive Messaging: Lawrence County “Tree of Life” Quilt

Designed and created by the Lawrence County Quilt Guild based on focus group themes.

Appliquéd tree in the center of the quilt represents life in Lawrence County.

Log Cabin and Appalachian Trail motifs in the borders reflect the history of the people living in this region of Kentucky.

Incorporates strong sense of pride about the beauty of the land, and the history, arts, and friendliness of the people of Lawrence County.

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Summary Incorporating personalized and targeted messaging about the synergistic, or combined, risk of exposure to tobacco smoke and radon is an innovative approach to decrease lung cancer and improve overall population. health.

Part Two:Impact of FRESH on Synergistic

Risk Among Homeowners

The project described was supported by Award Number R01ES021502 from the National Institute

of Environmental Health Sciences (NIEHS) and the National Institute of General Medical Sciences

(NIGMS). The content is solely the responsibility of the authors and does not necessarily represent

the official views of the NIEHS, NIGMS, or the National Institutes of Health.

Disclosure

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Hypothesis

Homeowners who received free home test kits (and instructions) and a

personalized environmental report back intervention for high nicotine and/or

radon levels would have higher perceived synergistic risk at 3‐months than those who do not receive FRESH.

FRESH Study Design RCT to test the effects of a dual home screening and personalized environmental report back intervention

Two recruitment strata

Smoker(s) living in the home (yes/no)

Two study groups

Treatment ‐ free radon and air nicotine home test kits in primary care settings and brief problem‐solving consultation

Control – coupon for free test kits at enrollment

Sample Quota sample of

homeowners (N=515) in the South recruited

in outpatient clinics, university locations, and community events.

319 completed the 3‐month survey.

153 and 166 homeowners were from treatment and control groups, respectively.

17% were current smokers.

43% had self‐reported SHS exposure in the home.

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FRESH Intervention Dual home screening for radon and SHS

Letters with results

Telephone conversation if radon >4.0 pCi/L and/or air nicotine > 0.1 μg/m3

Brief problem‐solving intervention

Mitigation

Smoking cessation

Smoke‐free home

Targeted printed materials

Measures Synergistic risk: single item asking participants to rate the risk from being exposed to radon AND smoking a pack of cigarettes per day, compared to the risk of only smoking a pack of cigarettes a day with no radon exposure.

5‐point Likert scale ranging from (1) ‘Much less risky’ to (5) ‘Much more risky.’

Demographic Characteristics of Sample of Homeowners (N =515)

Demographic characteristic Percent

Female 67.8%

White, non‐Hispanic 85.2%

College degree or higher 61.3%

Family history of lung cancer 23.9%

Lived with smoker 49.7%

Note: Mean age 51.2 years (SD = 12.7)

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Perceived Synergistic Risk by Study Group Over Time

p =.002 p =.40

Results

Between baseline and 3 months post‐intervention, there was a significant increase in perceived synergistic risk of radon and secondhand smoke among those in the treatment group (t=3.1, p = .002).

The control group’s synergistic risk scores did not change over time (t=0.8, p=.40).

Conclusions Dual home screening for radon and tobacco smoke and personalized environmental report‐back may enhance perceived risk for combined environmental exposures.

Distributing free radon test kits as part of the tobacco use assessment in primary care settings may increase radon testing.

Continued efforts to educate the public on the combined health effects of radon and tobacco smoke exposure and to motivate everyone (especially those with current and past tobacco smoke exposure) to test and mitigate for radon are critically important.

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Free Radon Continuing Education Course

www.breathe.uky.edu

Questions?

Karen M. Butler, DNP, RNProfessor & Assistant Dean of Academic Operations

Co‐Director, Radon Policy Division, BREATHEUniversity of Kentucky College of Nursing

[email protected]

LunchTime for

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Landscape of disparities in lung cancer care

M. PATRICIA RIVERA, MDPROFESSOR OF MEDICINE CO-DIRECTOR OF THE MULTIDISCIPLINARY THORACIC ONCOLOGY PROGRAMDIRECTORY LUNG CANCER SCREENING PROGRAM

DisclosuresM. Patricia Rivera, MD

I have no financial relationships to disclose.

I will not discuss off label use and/or investigational use in my presentation.

Defining Disparity

Racial and ethnic disparities in health care recognized and documented for decades

Landmark Whitehall Study in Britain, 1967, demonstrated an inverse relationship of social class and disease mortality (Marmot et al Lancet 1991)

WHO refers to health disparity as “the unfair and avoidable differences in health status seen within and between countries”

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Defining Disparity

Race and ethnicity are a “social classification based on phenotype and are markers for social factors, primarily socioeconomic status (SES), which influence health

Variables included in statistical models to quantify racial/ethnic disparities include level of education, income, and diet, are closely linked to environment and social context

SES measures such as level of education are not consistently collected in public health surveillance systems which may be adding complexity to disparity assessment

The scope of lung cancer

Leading cause of cancer death worldwide

2017 in the United States: 222,500 new cases (13% of all new cancer dx) 155,870 deaths (27% of all cancer deaths)

Overall 5 year survivorship: 17% (all comers) 58-73% in Stage 1 with surgery Only 15% present with early stage disease Screening with LDCT may result in stage shift

Siegel RL et al. CA CANCER J CLIN 2017;67:7–30 .

Goldstraw et al. Journal of Thoracic Oncology. 2007

“Smoking is the principal cause of lung cancer; it is estimated to be responsible for 85 per cent of all types of this cancer”

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Percentage of adults current cigarette smokersby health insurance status and education level US 2014

29.1

12.512.9

27.9

By Health Insurance Status

MedicaidOnlyMedicareOnlyPrivate

Unisured

5.89.1

19.8

24.7

29.8

By Education Level

Graduatedegree

4 yr college

Somecollege

High school

Less thanHigh school

Jamal A et al. MMWR Morbidity and Mortality Weekly Report 2015’ 64;1233-1240

Tobacco Companies Aggressively Target Minorities Philip Morris:“Marlboro will have a very difficult time getting anywhere in the young black market. Young blacks have found their thing, and it's menthol in general and Kool in particular.” (Roper Organization Inc. Smoking Habits among young smokers, Phillip Morris )

RJ Reynolds:“Since younger adult Blacks overwhelmingly prefer menthol cigarettes, continued emphasis on Salem within the Black market is recommended with emphasis on the younger adult Black market.”(RJR Consumer research Report 1984)

Tobacco Companies Aggressively Target Minorities

“Spanish-speaking consumers [are] extremely loyal to brands advertised but to win them takes more than simple translations of labels from English to Spanish. It requires regular advertising in order to build up confidence in the product but once that confidence is gained, they can be expected to be loyal forever”

“the newly arrived are less competent in the English language, less knowledgeable about American brands, and less sophisticated in their reactions to advertising on behalf of those brands”

Hispanic marketing action plan. May 29, 1984. Philip Morris

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Ethnic and Racial Differences in the Smoking-Related Risk of Lung CancerHaiman CA et al. NEJM 2006;354:333-

Prospective study

Almost 184,000 participants

Risk of lung cancer was ascertained according to the level of cigarette smoking and ethnic or racial background

Predicted Rates of Lung Cancer among:Men Who Smoke 10 cigs/day (Panel A) or 30 cigs/day (Panel B) Women Who Smoke 10 cigs/day (Panel C) or 30 cigs/day (Panel D)

Haiman, C. et al. N Engl J Med 2006;354:333-342

Among those who smoked no more than 30 cigarettes per day, the relative risk of lung cancer was highest among African Americans and native Hawaiians, as compared with whites, Hispanics, and Japanese Americans

Baseline Characteristics of the Participants


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Ethnic and Racial Differences in the Smoking-Related Risk of Lung CancerHaiman CA et al. NEJM 2006;354:333-

Higher level of education = decreased lung cancer risk: Participants who completed less than eight years

of school RR lung cancer 1.12 Vocational training (RR 0.73; 95% CI 0.56-0.95) Some college (RR 0.70; 95% CI 0.58 – 0.84)

Incidence Rates/ Relative Risks of Lung Cancer among Men and Women According to Ethnic or Racial Group, Histologic Cell Type, and Stage of Disease


- Blacks and Native Hawaiians (NH) had elevated riskof lung cancer at all stages

- Whites more likely to present with early stage disease c/w Blacks, NH and Latinos

- Blacks and NH more likely to present with metastatic disease

Stage at Diagnosis of Lung Cancer by Ethnicity SEER 2001-2003

Localized

10

30

50

Per

cent

age

of

Ca

ses

0

20

40

60

Regional

White

Black

Hispanic

Howe H et al. Annual Report to the Nation on the Status of Cancer. Featuring Cancer among US Hispanic/Latino Populations. Cancer 2006; 107:1711-1742

Distant

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Number of Deaths per 100,000 Persons by Race/Ethnicity & Sex: Lung and Bronchus Cancer

SEER Stat Fact Sheets: Lung and Bronchus Cancer 2008‐2012, US Age‐adjusted

Lung Cancer Deaths per 100,000

Among blacks with low SES, death rates are twice the national average

Lung Cancer Survival by Race and Gender

Female

White Female

Black Male

Black FemaleWhite Male

l SEER-Medicare 2004-2009

Racial/ethnic differences in lung cancer

Blacks more likely to develop and die from lung cancer than persons of any other racial or ethnic group.

Age-adjusted lung cancer incidence rate among black men, approximately 32 percent higher than for white men, even though overall exposure to cigarette smoke is lower

Lung cancer incidence rate for black women is roughly equal to that of white women, despite smoking fewer cigarettes.

U.S. National Institutes of Health. National Cancer Institute. SEER Cancer Statistics Review, 1975-2011.

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Treatment Disparities

Stage I and II NSCLC = gold standard surgical resection

Blacks with stage I or II NSCLC are less likely to receive surgery than whites Even if they have insurance and are at the same income

level. This disparity accounts for much of the difference in survival

rates

Singh et al. NIH publication No. 03-5417 Bach et al. NEJM 1999;341:1198- Hardy et al. Cancer 2009;115:2199-2211 Steele et al. J Natl Med Assoc 2011;103:711-718 Ganti et al. Clin Lung Cancer 2013;15:152-158

Increased rates of NO treatment in NSCLC

Significant advances in NSCLC treatment past 2 decades: Novel therapies offering improved survival Improvements in supportive care and side effect management

Expect: number of untreated patients with an advanced stage of NSCLC decrease over time

NCDB* (1998-2012): 190,539 NSCLC patients 21% of patients received no treatment Stage IIIA and IV:

Proportion of untreated patients increased over study period by 0.21% and 0.4%, respectively (p 0.003 and p < 0.0001)

Factors associated with receipt of NO TREATMENT: Female sex, non-white race, no insurance, low income, low

education NCDB = National Cancer Data Base

David E et al. J Thoracic Oncology 2016; 3:437-445

Race and Sex Differences in the Receipt of Timely and Appropriate Lung Cancer Treatment Seer data 1995-2009 22,145 patients

Women 25% less likely to receive timely surgical resection Black men less likely to receive resection (22% c/w 43.7% for white) Blacks 66% less likely to receive timely surgical resection compared to

whites Blacks were 34% less likely to receive timely chemo/RT for locally

advanced disease Blacks were 51% less likely to receive timely chemo for stage IV

Shugarman LR et al. Med Care 2009 47:774-

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Immunotherapy: Improved outcomes in patients with advanced NSCLC both in the front line and second line setting

Brahmer J et al. N Engl J Med 2015;373:123-135.

Reck M et al. N Engl J Med 2016; 375:1823-33

In Cancer Trials, MinoritiesFace Extra Hurdles

In one of the first studies conducted in 582 lung cancer patients, 92% were white and 3% black (NEJM 2015;373:123-135)

While a 1993 law states that all medical research conducted or paid for by the National Institutes of Health must include enough minorities and women, the NIH paid for about 6% of clinical trials in 2014

Immunotherapy trials in lung cancer are sponsored by pharmaceutical companies.

Such trials geared toward getting a drug approved and are done quickly.

Minority patients with low incomes and less awareness of medical studies are left out because it can take longer to fined and enroll them

Participation in Cancer Clinical Trials Race, Sex, and Age-Based Disparities

Murphy et al. JAMA 2004;291:2720-2726

Compared with a 1.8% enrollment fraction among white patients, lower enrollment were noted in Hispanic (1.3%; odds ratio [OR] and black (1.3%; OR, 0.71; 95% CI, 0.68- 0.74; P .001) vs white patients.

Although the total number of trial participants increased during the study period, the representation of racial and ethnic minorities decreased.

In comparison to whites, after adjusting for age, cancer type, and sex, patients enrolled in 2000 through 2002 were 24% less likely to be black (adjusted relative risk ratio, 0.76; 95% CI, 0.65-0.89; P .001).

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Explanation for Increased Risk:Variations in smoking behavior

Black smokers are twice as likely to smoke mentholated cigarettes compared with whites

Cummings K et al. Public Health Reports 1987; 102(6): 698–701

FDA Tobacco Products Scientific Advisory Committee: Menthol Cigarettes and Public Health: 2011 Menthol likely:

Has unique impact on youth, African-Americans and women Makes cigarettes less harsh and more palatable Longer and deeper inhalation Increases the number of children and young adults who start

smoking Makes cigarettes more addictive and quitting more difficult

(particularly for AA)

Explanation for Increased Risk:Variations in nicotine exposure and metabolism:

Blacks inhale more nicotine per cigarette smoked (30% higher) thus more exposure to carcinogens despite a low number of cigarettes smoked per day 1

Have lower cotinine clearance compared to white and Hispanic smokers after smoking the same number of cigarettes1,2

Cotinine half-life was higher in blacks than in whites (1064 vs 950 minutes, respectively; P = .07)2

1. Perez-Stable EJ wr al. JAMA 1998; 280:152-6.2. Wagenknecht LE et al. Am J Public Health 1990;80:1053-

Disparities in Tobacco Dependence Treatment

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Smoking Cessation Among Racial/Ethnic Minorities

Black smokers: Are at high risk of continued smoking and poor smoking cessation

outcomes1

Demonstrate greater intention and more attempts to quit, however, are less likely to receive quit advice from providers; to initiate, participate in, or adhere to tobacco treatment; or to maintain abstinence after quitting 2

When participate in tobacco treatment, rates of pharmacologic use to assist cessation efforts are lower 1,3

Possibly related to fear, distrust, or misconceptions regarding the efficacy, utility, and safety of these medications

Who smoke menthol cigarettes, despite smoking fewer packs per day, have decreased successful quit rate than those non-menthol smoking Blacks4

1. Centers for Disease Control and Prevention. Quitting smoking among adults -2001-2010. 2011:1513-1519

2. U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. 2014

3. Fu, S.S. et al. Am J Health Promot. 2005;20:108–116.

4. Gandhi KK, et al. Int J Clin Pract. 2009;63:360-367.


Hispanic/Latino smokers: Have high motivation to quit, with concern for health effects on

children and the family as a primary motivator, however, they mostly rely on themselves for cessation, with little use of cessation medication and support services1

Experience lower levels of practitioner intervention and physician advice to quit 2,3,

1. Carter-Pokras OD, et al. J Natl Med Assoc. May 2011;103(5):423-431.

2. Centers for Disease Control and Prevention. Quitting smoking among adults -2001-2010. 2011:1513-1519

3. Zinser MC, et al. Am J Health Promot. 2011;25(Suppl 5):eS1-15.


Systematically review literature (2010-2014) Smoking cessation intervention trials in racial/ethnic minority

groups Studies investigating factors associated with cessation

Results: Varenicline is promising among African Americans and Hispanics.

Culturally specific behavioral counseling appears to be efficacious among Asian Americans.

In trans-group comparisons, racial/ethnic minorities reported greater quit attempts compared to Whites; yet lower success rates

Success may be reduced due to factors such as menthol smoking, low pharmacotherapy use, and lower readiness to quit Webb Hooper et al.Curr Addict Rep 2015;2:24–32

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Quitting Smoking Among Adults United States, 2000–2015

MMWR January 6, 2017; 65:1457–1464

US population smoking cessation rates: Overall: 7.4% White non-Hispanic: 7.1% Black, non-Hispanic: 4.9% Hispanic: 8.2% American Indian/Native American: not reported (small sample

size) Asian, non-Hispanic: 17.3 Low SES 5.6 %

Quitting Smoking Among Adults United States, 2000–2015

MMWR January 6, 2017; 65:1457–1464

US population tobacco dependence treatment:Advice Counseling Medication Combination

Overall 57.2% 6.8% 29% 31%

White (NH) 60.2% 6.9% 32.6% 34.3%

Black (NH) 55.7% 7.6% 25% 28.9%

Hispanic 42.2% 5.1% 16.6% 19.2%

AI/AN 38% NA NA NA

Asian (NH) 69.6% NA 22% 24%

Disparities in Screening and Early Detection

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Proportions Screened for Cancer by Race/Ethnicity and Birthplace*

CA: A Cancer Journal for Clinicians

Pap Smear,†% screened

Mammogram,†% screened

Fecal Occult Blood Test,†% screened

Sigmoidoscopy,†% screened

•*All percentages are based on weighted analyses.•†P < .005 for each type of cancer screening by both race/ethnicity and birthplace.

Overall 84 72 27 29

Race/ethnicity

White, non-Hispanic 86 74 28 30

Black 88 70 24 26

Hispanic 77 66 18 20

AAPI 71 62 27 27

Birthplace

U.S.-born 86 73 27 30

Foreign-born 74 66 21 23

Little is known about lung cancer screening in minorities

Demographics: NLST vs. US populationNLST US Census Survey

Male/Female 59/41 58.5/41.5

Age 55-59 42.8 35.2

Age 60-64 30.6 29.3

Age 65-69 17.8 20.8

Age 70-74 8.8 14.7

% Black 4.4 5.5

% Hispanic 1.7 2.4

Current smoker 48.2 57.1

College education 31.5 14.4

Aberle, et al. JNCI. 2010

Most of the individuals randomized to the NLST (48,549, or 91%) were white and only 2378 (4.4%) were black.

Analyzed racial differences in outcomes between Black and white individuals who participated in the NLST

Self-reported data from the NSLT characterize subjects by racial background, gender,

age, marital status, comorbidities and education level

Main outcomes: LC-specific and All-cause mortality

Tanner, et al. AJRCCM 2015

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Results

Lung cancer mortality was reduced among all racial groups that were screened with LDCT More so in black individuals (hazard ratio 0.61 vs.

0.86)

Smoking increased the likelihood of death from LC, When stratified by race, black smokers were

twice as likely to die as white smokers (HR, 4.10 vs. 2.25).

Tanner, et al. AJRCCM 2015

Results

Blacks experienced higher all-cause mortality than whites (HR, 1.35; 95% CI, 1.22-1.49)

Blacks screened with LDCT had a reduction in all-cause mortality Does LDCT screening improve access to medical care?

Minorities less likely to have access to health care services in 2013: 18.9% of Blacks were uninsured Vs 12.1% of Whites1

In the NLST, 7 sites had targeted strategies for minority participation. These patients were less educated with lower incomes and less likely to have insurance.2

13.8% of minorities were uninsured vs 5% of white participants Detection of other abnormalities (CAC etc.)

1 Martinez et al, National Center for Health Statistics, 20142 Duda et al, Clinical Trials, 2011

Screening is a teachable moment for smokers to consider smoking cessation.1

Costs per QALY for smoking cessation is $1108 – 4542, LDCT screening is about $81,000 2

Primary aim: determine when abstinence would match results of NLST

Secondary Aim: determine differences in abstinence benefit related to race

Villanti et al, PLoS One, 2013 Black WC et al, N Engl J Med, 2014

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Results In NSLT: Former smokers in control arm abstinent for 7 years had

a 20% mortality reduction comparable to the benefit reported with LDCT screening

The combination of smoking abstinence and LDCT screening resulted in a risk reduction of 38% reduction in lung cancer-specific mortality (HR 0.62, 95% CI 0.51 – 0.76).

This is substantially greater than screening with LDCT alone suggesting one should not be done in absence of the other

Black former smokers (n=794) had a more pronounced benefit from smoking abstinence than their white counterparts (HR 0.53; 95% CI 0.28 to1.0)

Tanner et al. AJRCCM. March 2016

Disparities in Cancer Outcomes Disparities associated with

socioeconomic factors are greater than racial factors

Disparities are consistent with differences in risk factors: smoking, access to high quality screening, timely diagnosis and treatment for cancer

Disparities most pronounced for lung cancer (5x ↑ death rate in least educated men)

Eliminating disparity would avoid 60,37 deaths, 37% ↓ Cancer deaths

Siegel R et al. The impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin 2011;61:212-

Determinants of Disparity

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Factors that influence cancer disparities

Socioeconomic factors: Level of education often a marker for socioeconomic status

Overall cancer death rates in the least educated segment of the population is 2.6 times higher than those in the most educated segment

Largest socioeconomic disparity reported in lung cancer; death rate in men being 5 times higher for the least educated

Differences in lung cancer death rates reflect differences in smoking rates, inequities in access to health care (impact all aspects including screening), receipt of quality care once cancer diagnosed and differences in comorbidities

Factors that Influence Lung Cancer Disparities

Cultural beliefs:

Study of 352 lung cancer patients: 21% black, 20% Hispanic.

Baseline survey:

Demographics, comorbidities, disease and treatment beliefs, health literacy, discrimination experiences and mistrust

Follow up phone interviews

Outcomes:

Stage

Appropriate treatment

Lin JJ. Annals ATS 2014;11:489-495

Stage, N (%)Non-

minorityN=215

MinorityN=142

P-value

Early (I-II) 120 (62) 61 (47) 0.01

Late (III-IV) 73 (38) 69 (53)

Stage at time of Diagnosis

Minorities more likely to be diagnosed with advanced-stage lung cancer (53% versus 38%, p= 0.01).

Lin JJ. Annals ATS 2014;11:489-495

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ModelOR (95% CI) for Late-Stage

Diagnosis among Minorities

Unadjusted 1.86 (1.19-2.92)Adjusted for socio-demographic characteristics

1.76 (1.03-3.02)

Adjusted for socio-demographic characteristics, fatalism and mistrust

1.56 (0.85-2.87)

Adjusted Association Between Disease Beliefs and Late Stage Lung Cancer Diagnosis

After controlling for fatalism and medical mistrust, the association between minority status and advanced stage at diagnosis was not statistically significant

Factors that influence lung cancer disparities

Beliefs about lung cancer etiology, symptoms, and treatment were similar between minority and non minority groups (p > 0.05)

Fatalistic views and medical mistrust were more common among black patients (p < 0.05, for all comparisons) Surgery causes lung cancer to spread and surgery

will have bad side effects or complications

Lin JJ. Et al Annals ATS 2014;11:489-495

Factors that influence lung cancer disparities

Blacks were more likely to harbor negative treatment beliefs, fatalism and medical mistrust, partially explained disparities. Not as much among Hispanics

Blacks were less likely to receive stage-appropriate treatment (OR 0.50) compared with whites and Hispanics (40%, 57%, 60% respectively) even when adjusted for age, sex, marital status, insurance, income, comorbidities and PS.

No differences in treatment rates observed among Hispanics.

Lin JJ. Et al Annals ATS 2014;11:489-495

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Factors That Influence Lung Cancer Disparities Prospective study, 5 clinical centers in North and South Carolina

386 NSCLC patients eligible for resection 29% of patients were black

Surgical rate: 66% for white patients (n=179/273) compared with 55% for black

patients (n=62/113; P=. 05). Decisions against surgery:

Negative perceptions of patient-physician communication Negative perception of 1-year prognosis post-surgery

Surgical rates for blacks were particularly low when: 2 or more comorbid illnesses (13% vs 62% for <2 comorbidities; OR,

0.04 [95% CI, 0.01–0.25]; absolute risk, 49%) Blacks lacked a regular source of care (42% with no regular care

vs 57% with regular care; OR, 0.20 [95% CI, 0.10–0.43]; absolute risk 15%

Cykert et al. JAMA. 2010 June 16; 303(23): 2368–2376.

Minimizing disparities in tobacco treatment and lung

cancer screening

Increasing Access to Health Care!!

Affordable Care Act Guidance on Coverage of Tobacco-Cessation Treatment.*

A group health plan or health insurance issuer will be considered to be in compliance with the ACA’s requirement to cover tobacco-use counseling and interventions if it covers the following, without cost sharing or prior authorization:

1. screening of all patients for tobacco use; and 2. for enrollees who use tobacco products, at least two tobacco-cessation attempts per year, with coverage of each quit attempt including:•• four tobacco-cessation counseling sessions, each at least 10 minutes long (including telephone, group, and individual counseling), and •• any FDA-approved tobacco-cessation medications (whether prescription or over-the-counter) for a 90-day treatment regimen when prescribed by a health care provider.

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Increasing Access to Health Care!!

ACA requires tobacco treatment, private/state Medicaid do not 2015 only 9 states covered counseling and all 7 FDA approved

tobacco treatment drugs

ACA may expedite the narrowing racial gap in prevention and treatment of lung cancer: From 2010 to 2015, the proportion of blacks and

Hispanics who were uninsured halved ( 21% to 11%, and 31% to 16% respectively)

If maintained, these shifts should help to expedite progress in reducing socioeconomic disparities in tobacco cessation, cancer, as well as other health conditions

Siegel et al. CA Cancer J Clin 2017;67:7–30 Jamal et at MMWR 2015 McAfee et al. NEJM 2015; 372:5-7

Strategies designed for underserved populations

Tailor to Culture. In some communities, group events are preferred to individual activities

to promote social support and a family-like atmosphere. Ideally, a tobacco prevention/treatment education program is directed to a defined population and is sensitive to the social, economic and cultural issues affecting that population (McAdams, 2005).

Provide cultural competency training. Strategies to reach racial and ethnic minority populations should be

culturally relevant (recognize, affirm, and value diversity and equity). It may be useful to provide training in cultural competency to individuals who are working with a community so that they can learn more about the differences within and across communities and how these differences influence tobacco intervention design and implementation.

Strategies designed for underserved populations Involve the priority populations.

Partner with professionals and community members from the racial and ethnic minority community to plan, implement and evaluate the intervention and ensure that intervention materials include language, visual content and ideals that are consistent with the culture of this community. Minorities, especially Native Americans and Hispanics, may be more sensitive to message strategies focusing on the negative social aspects and family influence for smoking cessation.

Engage community stakeholders.

Leadership and active participation by community members can strengthen the credibility of and respect for the intervention. For example, support from healthcare providers or community and religious leaders from the racial and ethnic minority community can influence the success of the intervention

Use established settings.

Having meetings or events at convenient locations and times. It may be useful to align interventions with church or community social events, build social support within the community and offer culturally- appropriate incentives to encourage participation.

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Opportunities to address disparities

Nurse patient navigators Cancer patients who have patient navigators that provide culturally

appropriate, confidential, respectful, and compassionate care, experience better outcomes

Few studies of patient navigators for lung cancer patients and a paucity of nurse patient navigator interventions that are culturally appropriate for low income African American lung cancer patients

Matthews-Juarez, P. et al. Social Work Public Health 2011;26:349–365.

Hendren, S et al. BMC. 2010; 10:551.

Freeman, H. P. Cancer Epidemiol Biomarkers Prev 2012; 21:1614–1617.

Improved communication Relay benefits of screening Smoking cessation and treatment Clinical trials

Better access to clinical trials in the community A significant barrier to participation in cancer trials is travel distance to

centers conducting trials

A Cancer Center With a Food Pantry

Queens Hospital Cancer Center in New York, 92% of patients are from minority groups. 85% of those with cancer qualify for emergency Medicaid

The center has patients in about 35 trials and reaches out to disadvantage patients by: Bringing NIH clinical trials to the patients Collaborating with drug companies to enroll minority patients

Providing expedited language translation for consents Dedicated cancer research nurses

“I educate them. We have to protect them, mare make sure they getting a true impression of the study”

Operates a food pantry

The New York TimesBy DENISE GRADYDEC. 23, 2016

Conclusions

Disparities associated with socioeconomic factors are significant

Result in increased tobacco use, less effective tobacco cessation interventions, increased risk of developing and dying from lung cancer

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Conclusions Will CT screening be implemented in a way

that reaches those who need it most?

As we move forward with LDCT screening for lung cancer it is critical that we take into account cultural beliefs and socioeconomic barriers in order to reach underserved minorities

Conclusions

Simply eliminating disparities (bringing all up to highest level) would prevent more lung cancer deaths than, Crizotinib, doublet chemotherapy in elderly, CT screening, combined

Affordable healthcare for all members of a society is a human right

Panel Discussion

Craig Burrows, MD (Family Medicine, St. Claire Regional

Medical Center)

David Bailey, Jr. RT (R) (PACS/RIS Coordinator, St. Claire Regional

Medical Center)

Wendy Whitt, RN(Clinic Coordinator - Frenchburg, St. Claire

Regional Medical Center)

Jessica Burris, PhD (Assistant Professor of Psychology, Marky

Cancer Center)

Angela Criswell, MA (Senior Manager of Medical Outreach, Lung

Cancer Alliance)

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Continuing Education Credit

Successful CompletionFor successful completion of this continuing education program, participants must:

Sign appropriate attendance roster

Be present for the duration of the program

Complete the online evaluation within 7 days of they symposium. www.neahec.org/LCSeval (Authorization Code: 20170901)

NOTE: Nurses (CNE) and Certified Health Education Specialist (CHES) must complete and return a paper evaluation before leaving.

A statement of credit will be issued within two weeks following completion of all required documentation. For further information, please contact

KaSandra Hensley, Education Coordinator at kasandra.hensley@st-claire .

SymposiumLung Cancer

Smoking Cessation&

3rd Annual

COMINGSEPTEMBER 2018

THANK YOU!

Continuing Education Credit - Northeast Kentucky AHEC · 9/27/2017 6 16 TLC 2 – Provider Perspective • Before versus after • Staff and clinic engagement • Tools for discussion

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