© 2011 ENACCT Inc. All rights reserved. 1© 2014 ENACCT Inc. All rights reserved. 1 Preparing Patients for the Oncology Referral: The Role of the Primary.

© 2011 ENACCT Inc. All rights reserved. 1© 2014 ENACCT Inc. All rights reserved. 1

Preparing Patients for the Oncology Referral: The Role of the Primary Care Provider in Cancer Clinical Trials


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Continuing Education Credit

Physicians:

This course was previously approved for continuing education credit for physicians. No credit is currently offered.

To pursue credit approvals for course content, please contact a local continuing medical education provider in your community


Objectives

Clarify common misconceptions among primary care providers about cancer clinical trials

Reflect on your critical role, being the first point of contact for patient access and participation in clinical trials

Describe practical strategies referring physicians can take to effectively prepare patients for discussions with their oncologist about cancer clinical trials

Did You Know…?

Only 2% of primary care providers routinely discuss oncology clinical trials with their patients.

A physician’s recommendation is often the primary factor influencing patients’ decisions to enroll in a trial.

A 2004 article by Sherwood and colleagues indicated that provider attendance at cancer clinical trial education sessions consistently predicted referral.


Crosson, K., Eisner, E., Brown, C., & Ter Maat, J. (2001). Primary care physicians’ attitudes, knowledge, and practices related to cancer clinical trials. J Canc Educ,16(4), 188-192; Comis, R.L, Miller J.D, Colaizzi D, Kimmel L.G. Physician-Related Factors Involved in Patient Decisions to Enroll onto Cancer Clinical Trials. Journal of Oncology Practice, Vol 5, Issue 2, 2009 pp 50-56; Sherwood P., Give B., Scholnik A, Given C. J Cancer Education 2004; 19:58-65 To Refer or Not to Refer: Factors that Affect Primary Care Provider Referral of Patients with Cancer to Clinical Treatment Trials


Cancer Clinical Trials: Importance for Primary Care Providers


Quotes to Consider


Quotes to Consider

“I think the primary care provider can be a resource for general conversation about clinical trials rather than referring a patient for a particular clinical trial.”

“Oftentimes [patients] return back to our office because they have other concurrent medical problems, but we’ll have the opportunity to kind of reinforce or support their decision to enter a clinical trial….”

Larissa Neklyudov, MD, General Internist

Anthony T. McCormack, MD, Geriatric Medicine


What Are Cancer Clinical Trials?


Cancer Clinical Trials

Focus on developing new strategies for the prevention,

detection, and treatment of cancer and overall

improvement in the quality of life of…

People with cancer or

People at high risk for developing cancer

National Cancer Institute (2002a)


Types of Cancer Clinical Trials

Treatment

Prevention

Screening and Early Detection

Diagnostic

Genetics

Quality-of-Life/Supportive Care


Participation in Clinical Trials

About 20% of cancer patients are medically eligible for a

clinical trial 1; however…

Trial participation among adult cancer

patients remains low, at about 2.5% to 3%.2‒4

This rate is even lower among people of

color and the medically underserved.5‒7

1 U.S. Department of Health and Human Services (2004); 2 Sateren et al. (2002); 3 Christian and Trimble (2003); 4 National Cancer Institute (2002b); 5

Brawley (2000); 6 Murthy, Krumholz, and Gross (2004); 7 Stewart et al. (2007)


Cancer Clinical Trials: Myths and Facts


Myth 1

Clinical trials have nothing

to do with my day-to-day

medical practice


FACT: Yesterday’s Trials Are Today’s Improved Treatments

Standard treatment options today are based on

the results of past clinical trials, resulting in…

Changes in clinical practice

Decreases in morbidity and mortality

Creation of more-effective treatment options

Improved quality of life for people diagnosed

with cancer


Improved Treatment Has Had a Large Impact on Survival Rates

* Five-year relative survival rates based on follow-up of patients through 2002.** Recent changes in classification of ovarian cancer have affected 1995–2001 survival ratesSEER Program, 1975–2002, Division of Cancer Control and Population Sciences, National Cancer Institute (2005)


FACT

Most cancer patients are interested in clinical trials but are never told about the opportunity.

Comis RL et al. A Quantitative Survey of Public Attitudes Towards Cancer Clinical Trials (2000), http://www.cancertrialshelp.org/CTHpdf/308-9.pdf; Comis RL et al. J Clin Oncol (2003)


Clinical Trials: Quality Care

Access to cancer clinical trials: an established standard

for the delivery of quality comprehensive cancer care

American College of Surgeons Commission on Cancer



Lack of access to equal treatment may

contribute to treatment and outcome

disparities, especially for the medically

underserved

Some have suggested that clinical trials

participation may be able to help reduce

those disparities

Institute of Medicine. The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved (1999)



Some studies have suggested that research

participation may be associated with

improved clinical outcomes

These data have led some to recommend trial

participation as a means to better treatment

Daugherty C et al. J Clin Oncol (1995); Joffe S, Weeks JC. J Natl Cancer Inst {2002); Yuval R et al. Arch Intern Med (2000); Karjalainen S, Palva I. BMJ (1989); Davis S et al. Cancer (1985); Marubini E et al. Lancet. (1996); National Comprehensive Cancer Network (2006); Lara PN et al. J Clin Oncol (2001)


Myth 2

Primary care providers have no role to play in encouraging their patients diagnosed with cancer to consider clinical trials as a treatment option.


FACT: Your Influence Is Key

Patients are willing to participate but rarely get

asked.

Oncologists are the ones who talk most to

patients about clinical trials, but it is important

for primary care providers to introduce the

option because they are your patients, before,

during, and after their cancer treatment.


Patients Are Willing to Participate and Need to Be Invited

Most patients would consider a clinical trial if their doctors recommended they do so.1

All who are eligible are not offered the opportunity to participate by their treating physician.

20% or fewer of all cancer patients are ever told about the option of receiving treatment through a clinical trial.2,3

People from minority groups are even less likely to be offered participation.4,5

1 Harris Interactive (2002); 2 Comis et al. (2000); 3 Comis et al. (2003); 4 Sateren et al (2002); 5 Simon and Du (2004)


Myth 3

Clinical trials are only for patients who have run out of other treatment options.


FACT: A Part of High-Quality Cancer Care for Individual Patients

High-quality treatment options are open to many

cancer patients, even for first-line treatment.

“The best management of any cancer patient is in

a clinical trial.” — NATIONAL COMPREHENSIVE CANCER

NETWORK Clinical Practice Guidelines in Oncology

“Therapies offered through cancer clinical trials

should ideally be considered the preferred

treatment choice for physicians and patients….”

— INSTITUTE OF MEDICINE

Braunholtz DA, Edwards SJL, Lilford RJ. J Clin Epidemiol 2001;54:217–224; Peppercorn JM, Weeks JC, Cook EFC,Joffe S. Lancet 2004;363:263–270


Clinical Trial Phases at a Glance

Phase I» Study questions: How should the treatment be given?

What dosage is safe?» Participants: People with no other treatment options

(n = 15 to 30)

Phase II» Study question: Is the treatment effective?» Participants: People with few treatment options (n <

100)

Phase III» Study question: Is the new treatment (or new use of a

treatment) better than current practice?» Participants: Varies; many patients receive first-line

treatment through phase III trials (n = 100’s to 1,000’s)


Benefits of Participation in Clinical Trials

Patients are closely monitored

Early access to investigational treatments

Participation in advancing medical knowledge

Active role in their own cancer care


Risks of Participation in Clinical Trials

Investigational treatments may not be better

than standard care.

There may be unexpected side effects.

May not work for every patient.

The patient may bear additional costs.


Costs and Other Trial Participation Concerns

What is covered by health insurance and

what is not?

» Medicare, Tricare, VA

What about eligibility?

» There are strict eligibility criteria

» May have a disproportionate effect on minority

patients


Myth 4

My patients will be

treated like “guinea

pigs” if they

participate in a clinical

trial.


Past Research Abuses

US Public Health Service Study of Syphilis in the Negro Male

Jewish Chronic Disease Hospital

Willowbrook Study


Informed Consent Protects Patients’ Rights

Informed consent is a process. Patients are told about:

Purpose of the study

Procedures—what’s going to happen and when

Risks and potential benefits

Their individual rights


FACT: Placebos Are Never Used in Place of Appropriate Treatment

Patients never receive a placebo instead of appropriate treatment.

In phase III randomized studies, patients receive either standard care or the new agent/approach being tested.

In earlier-phase studies, all patients receive the same agent.


Myth 5

Clinical trials are only

available at large

academic medical

centers in big cities.

FACT: Cancer Clinical Trials Are Available in Many Local Communities Too

Cancer clinical trials take place in many settings, not just academic centers; many, over 60% occur at the community level


Enhancing Cancer Treatment through Improved Understanding of the Critical Components, Economics and Barriers of Cancer Clinical Trials. C-Change and Coalition of Cancer Cooperative Groups, 2006.


Myth 6

Helping my newly

diagnosed patients (or

patients being referred

for a diagnostic work-up)

gain access to cancer

clinical trials is going to

take too much time and

effort and should only

occur with the

oncologist, not me.


FACT: Cancer Treatment Options—Part of What You Already Discuss

Many of you…

» play an active role in cancer patient management;

» believe that discussing cancer treatment options

with your patients is part of your role and

responsibilities; and

» are already proactive in communicating with your

patients about cancer treatment options.

Mentioning cancer clinical trials in your

discussions with your patients complements

what you already do.Klabunde CN, Ambs A, Keating NL, et al. J Gen Intern Med 2009;24(9):1029–1036.


What You Can Do: Mention Clinical Trials as an Option for Treatment

First, discuss what your patient should expect

from diagnostic workup procedures in

general.

Next, discuss what to expect from treatment

options in general.

Then, mention clinical trials as a viable

treatment option.


One Quick Way to Say It

“I’m going to refer you to an

oncologist, who can talk

about your treatment

options in more detail. Ask

him/her about clinical trials,

because it’s a quality

treatment option for many

patients.”


Another Way to Say It

“[Providers] should be able to let the patient know that clinical trials do have the potential benefits on society and other patients by enhancing the knowledge and our understanding. A clinical trial may help the patient directly, but it may not. And that the patient really needs to know about the potential benefits and the potential risks of any trial before they sign on the dotted line.”

Larissa Neklyudov, MDGeneral Internist

© 2014 ENACCT Inc. All rights reserved. 41

More You Can Do

Provide patient education

materials—either directly to

patients or made available in

waiting areas and exam room.

Refer patients only to

oncologists and surgeons who

participate in local clinical

trials (or who will refer

patients to clinical trials).To order:

1-800-4-CANCERwww.cancer.gov


Provider Discussion, Post Referral

Primary care provider–patient communication

beyond referral

“…It’s quite important for the primary care doctor to

realize that their role doesn’t end with the referral to

the medical oncologist.”

“…The primary care doctor as a person with a longer

standing relationship with the patient than the

oncologist, whom they are just starting to see…are put

in a perfect position to either support or refute the

recommendation for clinical trials, whether they know

about the detail of the trial or not. If they simply

understand that clinical trials are a good thing to

recommend, it allows us to get their support.”

Jay Zatzkin, MDMedical Oncologist


Patient Case Studies


Consider Your Role in Cancer Care

Susan Jenkins, 56 years old, has been sent for a routine mammogram. Due to suspicious findings, she is now being referred to a surgeon, who confirms her cancer diagnosis and mentions clinical trials as a treatment option. Susan has now made a follow-up appointment with you and is asking questions about the pros and cons of her treatment options.


Patient Questions and Concerns: How Would You Answer?

“The surgeon told me about a

clinical trial, but isn’t that only

for people who are really sick?

What do you think I should do?”


Possible Responses

Clinical trials are not only for those with the

most advanced disease.

Many patients with many different types of

cancer receive their first treatment as part of

a clinical trial.

Other patients participate in clinical trials

after they have already been treated with one

or more standard treatments.



Maria Flores, 48, has chronic myelogenous leukemia. She has been seen by you for routine care since completing cancer treatment 3 years ago. Following an appointment with you for routine care, at which she presented with suspicious symptoms, she returns to her oncologist for further testing; it’s discovered that she’s experiencing a recurrence. After meeting with the oncologist, who mentioned a clinical trial that she may be eligible for, she comes back to you to discuss her treatment options.



“My cancer doctor said there’s

a study I can join, but that I

may not get the new treatment

being tested. Why can’t I just

get the new treatment if it’s

available? It’s better than

what’s already out there, isn’t

it?”

Cheung WY et al. J Clin Oncol 2009;27(15):2489–2495; Nekhlyudov L. J Clin Oncol 2009;27(15):2424–2426.


Possible Responses

Patients are assigned to different groups in a trial, and this selection is done by a computer. Neither doctors nor patients can choose the group they are assigned to.

This helps prevent study results from being affected by a doctor's beliefs or choices—and helps keep the groups as similar as possible and, therefore, comparable.

If the new approach being tested in the trial was already known to be better than standard care, there would be no need for the study.

49



Louis Green is a 62-year-old African-American man with Medicaid and blood in his urine for “a few weeks.” A DRE revealed an enlarged prostate. The results of his blood work indicate a PSA level of 12.0. Your office staff contacts Mr. Green to return to the office to discuss the findings.



“I don’t think I’d want to hear

anything about taking part in

a study for my treatment—I

don’t want to be a guinea pig

in some experiment.”


Possible Responses

Patients who participate in clinical trials have both rights and protections to make sure their privacy and well-being are maintained.

One of the most important protections is informed consent—a process does not end once the form is signed.

Conduct of trials is overseen by local review boards, and clinical findings of national studies are monitored by Data Safety Monitoring Boards.

Participation is voluntary, and patients can leave a study at any time.


Consider Your Critical Role

In ensuring your patients receive quality cancer care:

Refer to oncologists who participate in clinical

trials.

Educate patients about the importance

of cancer clinical trials as an option for

first-line treatment.

Encourage patients to ask the oncologist

if there is a clinical trial that is right for him or

her.


Thank You

© 2011 ENACCT Inc. All rights reserved. 1© 2014 ENACCT Inc. All rights reserved. 1 Preparing Patients for the Oncology Referral: The Role of the Primary.

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