I-SPY 2  Network of Strength Partnership Peer Counselor Training

I-SPY 2  Network of Strength PartnershipPeer Counselor Training April 2010

Goals for Peer Counselor Training 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

Topics For Peer Counselor Training  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

What is a Clinical Trial? 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

What are the Pros and Cons of Participating in a Clinical Trial? • 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 Pros Cons

Take Home Points About Clinical Trials 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

Useful Resources About Participation in Clinical Trials • 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

What are the Goals and Objectives of I-SPY 2? 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

Who Can Participate in I-SPY 2? 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

I-SPY 2 Steps Recruit Patients Enroll Patients Treat Patients Support Patients Peer Counselors

Recruiting Patients Make Patients Aware of Trial Screening Consent Discussion Yes Yes Yes Interest? Agree? Eligible? No No Done I-SPY 2 Brochure I-SPY 2 Patient Website; DVD Non-Eligibility Discussion Decline Questionnaire

Two Step Informed Consent Process: Screening • 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

Enrolling Patients Randomize (Determine Treatment) Treatment Consent Discussion Yes Yes Eligible? Agree? Yes No No Non-Eligibility Discussion I-SPY 2 Patient Website & DVD Decline Questionnaire

Two Step Informed Consent Process: Treatment • Follows patient randomization • Provides detailed description of I-SPY 2 • Goals • Patient scheduleSpecific 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

I-SPY 2 Use of Network of Strength Peer Counselors 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.

Network of Strength Counselor Request Form 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. Name: Address: Nancy L. Nixon Director--Contact Center Breast Cancer Network of Strength(r) 300 W. Adams St., Suite 430 Chicago, IL 60606

Treatment Consent MRIBlood Draw MRIBlood Draw MRIBiopsyBlood Draw MRIBiopsyBlood DrawMUGA/EchoPET/CT Scan Treating Patients Randomize On Study Taxol +/- Herceptin+/- New Drug(12 weekly cycles) AC(4 monthly cycles) Surgery Screening Tissue -

Standard Treatment During I-SPY 2 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.

Treatment Beyond Standard of Care in I-SPY 2 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

Peer Counselor Support for I-SPY 2 Patients Shortly After Enrolled After First Treatment - After Completion of Taxol Prior to Surgery Following Surgery

I-SPY 2Clinical Trial Background Info about I-SPY 2(in binder) • 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 Tab 4 Tab 6

Topics For Peer Counselor Training  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

What Support will be Available for Patients Enrolled in I-SPY 2? Introductory brochure Patient DVD User friendly I-SPY 2 patient website Other support provided by individual trial sites

Navigating the Website

Navigating the I-SPY 2 Website

Goals for Peer Support: Patients Enrolled in I-SPY 2 • 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

Likely Concerns of Patients:Treatment Issues • Neoadjuvant therapy • Multiple biopsies • Multiple MRIs • Investigational drugs Issue Potential Resolution

Likely Concerns of Patients:Logistical Issues • Potential insurance concerns • Time, cost, and inconvenience of extra clinic visits • Distance to trial site • Change of doctor Issue Potential Resolution

Likely Concerns of Patients:Other Issues Issue Potential Resolution

Potential Post-Enrollment Calls Shortly After Enrolled After First Treatment - After Completion of Taxol • For all call: • Check current status and discuss patient issues • Check compliance and help patient articulate issues for health care provide • Anticipate next steps of treatment • Schedule next call Prior to Surgery Following Surgery

Call One • 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

I-SPY2: Beginning Treatment 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”

Emotions 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.”

Role Play a Patient Discussion • 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

Call Two • 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

Call Three • 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

I-SPY 2: Mid- Treatment Concerns 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.

Treatment Concerns Caller Concern: Side effects, such as nausea and joint pain, that might be the result of some chemo Peer Counselor Support • Possible 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 nausea • The 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.

Call Four • 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

Call Five • 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

I-SPY 2: After Surgery 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.

Continuing Concerns 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.

I-SPY 2  Network of Strength Partnership Peer Counselor Training