April 2010 1. Ensure all counselors are familiar with the pros and cons of participation in clinical trials Ensure all counselors are familiar with.

April 2010

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Ensure all counselors are familiar with the pros and cons of participation in clinical trials

Ensure all counselors are familiar with patient requirements and schedules that are involved in the I-SPY 2 clinical trial

Provide counselors with suggestions for assisting I-SPY 2 patients

Ensure that counselors are familiar with appropriate I-SPY 2 expectations and record keeping procedures

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The what and why of clinical trials

Introduction to I-SPY 2 I-SPY 2 patient support materials Supporting patients undergoing

neoadjuvant treatment Network of Strength processes

for I-SPY 2 Q & A and Summary

Research that carefully tests new ways to prevent, diagnose, or treat diseases like breast cancer

A study that includes only patients who choose to participate

An important way to advance science and develop better therapies for patients with diseases similar to those being treated in the trial

A method whereby patients are randomly assigned to receive standard treatment OR standard treatment plus an investigational drug

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Pros Cons

Treatment by a team of first rate clinicians at a comprehensive cancer center

More, and possibly better, attention

Potential to receive a new, beneficial drug

Opportunity to contribute to the advancement of science

Possible need to travel farther for treatment

Possibility of receiving a new drug that provides no additional benefit but may add side effects

Additional visits to the clinic and additional laboratory procedures

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Enable advancement of science Provide a good option for patients seeking

treatment Are not right for everyone Should inform patients about pros and cons Never pressure patients to participate

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◦ From NCI: http://www.cancer.gov/clinicaltrials/learning/clinical-trials-education-series

◦ From Dana Farber: http://www.dana-farber.org/res/clinical/trials-info/default.html

◦ From ACS: http://www.cancer.org/docroot/ETO/content/ETO_6_3_Clinical_Trials_-_Patient_Participation.asp

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The what and why of clinical trials

Introduction to I-SPY 2 I-SPY 2 patient support materials Supporting patients undergoing

neoadjuvant treatment Network of Strength processes

for I-SPY 2 Q & A and Summary

The purpose of I-SPY 2 is to learn: Whether patients with breast cancer benefit

from adding an investigational drug to standard chemotherapy

Which investigational drugs are most likely to work for which subtypes of breast cancer, based on biomarkers

What changes these drugs make on tumor biomarkers and MRIs

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Women who: Are newly diagnosed with stage II or III

breast cancer Have a tumor equal to or greater than 2.5cm Have a biomarker profile indicating a high

risk of recurrence with standard treatment, based on:◦ ER/PR status◦ HER2 status◦ MammaPrint results

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Recruit Patients

EnrollPatients

Treat Patients

SupportPatientsPeer

Counselors

Agree?

Make Patients Aware of

Trial

Screening Consent

Discussion

Interest?

Eligible?

Done

Yes Yes

NoNo

Non-Eligibility

Discussion

Decline Questionnair

e

Yes

I-SPY 2 Brochure

I-SPY 2 Patient

Website; DVD

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Provides general description of I-SPY 2◦ Goals◦ Patient schedule◦ Risks and benefits◦ Financial issues

Provides specific information about eligibility requirements and screening procedure

Does not provide specific information about drugs

Requests patient’s agreement to be screened

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Randomize(Determine Treatment)

Eligible?

Agree?Treatment Consent

Discussion

No

Yes

Non-Eligibility

Discussion

Decline Questionnair

e

No

Yes

Yes

I-SPY 2 Patient

Website & DVD

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Follows patient randomization Provides detailed description of I-SPY 2

◦ Goals◦ Patient schedule

Specific drug side effects Standard drugs (Taxol and AC) in treatment consent Herceptin and experimental drugs in supplemental consent

◦ Risks and benefits◦ Financial issues◦ Withdrawal process

Requests patient’s agreement to be treated in I-SPY 2

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During treatment, informed consent patients are offered phone calls of support from a Network of Strength peer counselor; if interested, patients sign and return a pre-stamped request form.

Patients may, alternatively, note the phone number and call if and when they please.

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Peer Support Facing a cancer diagnosis can be traumatic and making treatment decisions can be challenging, including whether or not to participate in a clinical trial. Many women in your situation find it helpful to speak with someone who has already gone through this experience. The Breast Cancer Network of Strength (formerly Y-ME) was founded in 1978 to provide peer-to-peer support to meet the needs of newly diagnosed breast cancer patients. They run a 24-hour, 7-day a week Support Center (800-221-2141) that is staffed by trained and certified breast cancer survivors to provide emotional support, information, and help people affected by breast cancer. Spanish and English counselors are available to answer calls at all times, and interpreters are available for callers who are not English or Spanish speakers. This service is available to anyone at any time, even if you do not join the I-SPY 2 TRIAL.Are you enrolling in the I-SPY 2 TRIAL?If you are enrolling in the I-SPY 2 TRIAL, you can have a Breast Cancer Network of Strength counselor who has been trained to know about the trial assigned to you. She will call you and schedule regular calls, approximately once per month, as you are undergoing your treatment. The counselor can help you talk about the emotions you are feeling with your diagnosis and treatment, discover useful ways to cope, identify questions you have for your doctors, and help answer questions about I-SPY 2 study procedures.Just provide the following information, fold and place in the mail.

Date:Patient’s Name:Preferred Phone Number:Call Time Preferences:Email:Primary Language:Trial Site:Enrollment Date:Biomarker Profile:Treatment Arm:

To be completed by Network of Strength StaffNetwork of Strength Counselor:Assignment Date:

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Screening

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Tissue-

MRIBlood Draw

MRIBlood Draw

MRIBiopsy

Blood DrawMUGA/Echo

PET/CT Scan Treatment Consent

MRIBiopsy

Blood Draw

Taxol +/- Herceptin+/- New Drug

(12 weekly cycles)

AC(4 monthly cycles)

Chemotherapy is given prior to surgery (neoadjuvant treatment).

Standard chemotherapy includes Taxol, AC, and Herceptin (if HER2+).

Surgery takes place approximately 6 months after the first treatment.

Hormonal treatment and/or radiation therapy is given after surgery to patients, if indicated.

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Three additional biopsies Three additional MRIs Investigational drugs—given to 80% of

patients Investigational drugs—given because they

are expected to work for a patient’s specific type of breast cancer

Research drugs and procedures—paid for by trial sponsors, but patients or their insurers pay for standard treatment

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Shortly After Enrolled

After Completion of Taxol

Prior to Surgery

After First Treatment

Following Surgery

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Tab 4 Tab 6

I-SPY 2 Trial Site Contacts I-SPY 2 Fact Sheet I-SPY 2 Executive Summary Nature Article I-SPY 2 Press Release I-SPY 2 Advocate FAQs I-SPY 2 Patient Website

Content

I-SPY 2 Overview Brochure I-SPY 2 Patient DVD NCI Taking Part in Cancer

Treatment Research Studies NCI Chemotherapy and You:

Support for People With Cancer

NCI Adjuvant and Neoadjuvant Therapy for Breast Cancer

Agendia MammaPrint Patient Brochure

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The what and why of clinical trials

Introduction to I-SPY 2 I-SPY 2 patient support

materials Supporting patient undergoing

neoadjuvant treatment Network of Strength processes

for I-SPY 2 Q & A and Summary

Introductory brochure Patient DVD User friendly I-SPY 2

patient website Other support provided

by individual trial sites

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The what and why of clinical trials

Introduction to I-SPY 2 I-SPY 2 patient support materials Supporting patients

undergoing neoadjuvant treatment

Network of Strength processes for I-SPY 2

Q & A and Summary

Provide participants with an opportunity to discuss their diagnosis and treatment issues with trained peer counselors◦ Validation of emotions and support for handling

them◦ Questions about the trial

Encourage participants to comply with trial requirements and raise concerns with their health care provider

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Issue Potential Resolution

Neoadjuvant therapy Multiple biopsies Multiple MRIs Investigational drugs

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Issue Potential Resolution

Potential insurance concerns

Time, cost, and inconvenience of extra clinic visits

Distance to trial site Change of doctor

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Issue Potential Resolution

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Shortly After Enrolled

After Completion of Taxol

Prior to Surgery

After First Treatment

Following Surgery

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Ideal Time: Within one week of enrollment

Goals of Call◦ Check current status and discuss patient issues◦ Check compliance and assist patient to identify issues for health care

providers◦ Review key components of I-SPY 2◦ Remind patient of treatment team members and roles◦ Suggest review of I-SPY 2 support material, if needed◦ Anticipate next steps of treatment◦ Schedule second call

Suggestions◦ ◦ ◦

Caller Concerns Wants to know more about MammaPrint test Is having second thoughts about participating in a

clinical trial—extra visits and being a “guinea pig” Is concerned about neoadjuvant therapy

Peer References MammaPrint brochure and website:

http://www.agendia.com/pages/about_mammaprint/75.php

“Taking Part in Cancer Treatment Research Studies” and I-SPY 2 DVD

“Adjuvant and Neoadjuvant Therapy for Breast Cancer”

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Caller Concerns: Feeling anxious and a bit fearful of starting the clinical trial

Peer Counselor Support “Feeling anxious and fearful is common when

starting a clinical trial.” “It’s important to remember that you will be

treated at a comprehensive cancer center and will receive standard treatment and possibly a new beneficial drug.”

“Those leading the clinical trial want you to do well and will monitor you very closely.”

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Divide into groups of three Assign roles

◦ Patient◦ Peer counselor◦ Observer

Role play for about 6 minutes Debrief with group members to discuss their

feelings and observations Rotate roles and scenarios, time permitting

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Ideal Time: Within two weeks of first chemo treatment

Goals of Call◦ Check current status and discuss patient issues◦ Check compliance and assist patient to identify issues for

health care providers◦ Review of key components of I-SPY 2◦ Remind patient of treatment team members and roles◦ Suggest review of I-SPY 2 support material, if needed◦ Anticipate next steps of treatment◦ Schedule third call

Suggestions◦ ◦ ◦

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Ideal Time: Between next to the last Taxane and second AC

Goals of Call◦ Check current status and discuss patient issues◦ Check compliance and assist patient to identify issues for health care

providers◦ Review key components of I-SPY 2◦ Remind patient of treatment team members and roles◦ Suggest review of I-SPY 2 support material, if needed◦ Anticipate next steps of treatment◦ Schedule fourth call

Suggestions◦ ◦ ◦

Caller Concerns Patient worries that her cancer is not shrinking Patient wonders why she needs AC when her scans are looking good

Peer Counselor Support‣ Not Shrinking. Suggest that patient discuss her MRIs with her doctor;

remind her that she still has more treatment and not all cancer reacts immediately to chemotherapy.

‣ Shrinking. Remind her that chemo is meant to kill any cancer cells throughout her whole body, not just in her breast. AC is still standard of care, but some patients do forego it. She should discuss this with her doctor.

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Caller Concern: Side effects, such as nausea and joint pain, that might be the result of some chemo

Peer Counselor SupportPossible side effects of chemo can be scary; however, she should remember that many people have no, or just a few, side effects.Taxol and Herceptin may cause mild muscle pain and nauseaThe doctor can prescribe several medications that will help with symptoms.Recommend that she keep her clinical team informed of any side effects, ensuring that appropriate meds are given and enabling her to feel her best during the trial.

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Divide into groups of three Assign roles

◦ Patient◦ Peer counselor◦ Observer

Role play for about 6 minutes Debrief with group members to discuss their

feelings and observations Rotate roles and scenarios, time permitting

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Ideal Time: About one week prior to surgery

Goals of Call◦ Check current status and discuss patient issues◦ Check compliance and assist patient to identify issues for health

care providers◦ Review key components of I-SPY 2◦ Remind patient of treatment team members and roles◦ Suggest review of I-SPY 2 support material, if needed◦ Anticipate next steps of treatment◦ Schedule fifth call

Suggestions◦ ◦ ◦

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Ideal Time: About one week after surgery

Goals of Call◦ Check current status and discuss patient issues◦ Discuss outcome of surgery (e.g., pathological complete

response—pCR)◦ Discuss follow-up◦ Discuss continuing concerns◦ Discuss availability of future support

Suggestions◦ ◦ ◦

Caller Concerns‣ Having second thoughts about not having had reconstructive

surgery‣ Worrying about not having a pathological complete response

(pCR)‣ Experiencing late side effects

Peer Counselor Support‣ Reconstruction. Options and/or a recommendation for a

consultation with a plastic surgeon can be discussed; reconstruction has no time limit.

‣ pCR. Many patients do not have pCR but do very well, especially those whose tumor was ER+ and who haven’t started endocrine therapy.

‣ Late Side Effects. Such fears are common; if something unusual persists, she should talk to her oncologist.

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Caller Concern: Wants to know how to get answers to her ongoing concerns during the clinical trial

Peer Counselor support‣ Get questions answered now and throughout the

clinical trial.‣ Maintain an open conversation with the medical

team.‣ Put together a list of questions for the doctor . ‣ Search a few websites that offer a wealth of

information on the clinical trial.

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Divide into groups of three Assign roles

◦ Patient◦ Peer counselor◦ Observer

Role play for about 6 minutes Debrief with group members to discuss their

feelings and observations Rotate roles and scenarios, time permitting

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Caller Concern: Caller wants to know how to get answers to all her ongoing concerns during the clinical trial

Peer Counselor support‣ Get questions answered now and throughout

the clinical trial.‣ Maintain an open conversation with the

medical team.‣ Put together a list of questions for the doctor. ‣ Search a few websites that offer a wealth of

information on the clinical trial.

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The what and why of clinical trials

Introduction to I-SPY 2 I-SPY 2 patient support materials Supporting patients undergoing

neoadjuvant treatment Network of Strength

processes for I-SPY 2 Q & A and Summary

Getting assigned to new patients Scheduling calls Addressing additional patient concerns Addressing additional peer counselor

questions Maintaining information in the Network of

Strength Support Center Participating in monthly conference calls

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During the treatment consent, patients will be provided with a “Network of Strength Counselor Request”◦ If a patient fills out and returns the self-

addressed/pre-stamped form, she will be assigned an I-SPY 2 peer counselor

◦ Patients who do not wish a specially assigned counselor may still call the hotline at 800-221-2141 any time (24x7)

Nancy Nixon assigns peer counselors Peer counselors schedule calls with patients

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Peer Support Facing a cancer diagnosis can be traumatic and making treatment decisions can be challenging, including whether or not to participate in a clinical trial. Many women in your situation find it helpful to speak with someone who has already gone through this experience. The Breast Cancer Network of Strength (formerly Y-ME) was founded in 1978 to provide peer-to-peer support to meet the needs of newly diagnosed breast cancer patients. They run a 24-hour, 7-days a week Support Center (800-221-2141) that is staffed by trained and certified breast cancer survivors to provide emotional support, information and help people affected by breast cancer. Spanish and English counselors are available to answer calls at all times, and interpreters are available for callers who are not English or Spanish speakers. This service is available to anyone at any time, even if you do not join the I-SPY 2 TRIAL.Are you enrolling in the I-SPY 2 TRIAL?If you are enrolling in the I-SPY 2 TRIAL, you can have a Breast Cancer Network of Strength counselor who has been trained to know about the trial assigned to you. She will call you and schedule regular call, approximately once per month, as you are undergoing your treatment. The counselor can help you talk about the emotions you are feeling with your diagnosis and treatment, discover useful ways to coping, identify questions you have for your doctors, and help answer questions about I-SPY 2 study procedures.Just provide the following information, fold and place in the mail.

Date:Patient’s Name:Preferred Phone Number:Call Time Preferences:Email:Primary Language:Trial Site:Enrollment Date:Biomarker Profile:Treatment Arm:

To be completed by Network of Strength StaffNetwork of Strength Counselor:Assignment Date:

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Situation Appropriate Response

Patient has questions about I-SPY 2 or other concerns that you cannot address

You have questions about how best to support patients in I-SPY 2

You have questions about logistics

Tell her to talk to or raise these issues with her health care provider

Contact Bev Parker [email protected] (630) 373-5722

Contact Nancy [email protected](312) 294-8552 

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The what and why of clinical trials

Introduction to I-SPY 2 I-SPY 2 patient support materials Supporting patients undergoing

neoadjuvant treatment Network of Strength processes

for I-SPY 2 Q & A and Summary

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“The only dumb question is the one not asked.”