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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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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.”
