1. Why do patients participate in clinical trials? 2. Overview of I-SPY2: Interacting with patients 3. Helping patients decide whether or not to participate in the I-SPY2 clinical trial 4. Patient support materials and services 5. Recruitment & retention 

 A research study that carefully tests new ways to prevent, diagnose, or treat diseases like breast cancer  Only patients who choose to take part in them  An important way to advance science and develop better treatments for patients with diseases similar to those of participants in the trial  Patients are typically randomly assigned to receive standard treatment OR standard treatment plus and investigational drug

ProsCons  Treatment at a Comprehensive Cancer Center, by a team of first rate team of clinicians  More, and possibly better attention  Potential to receive a new, beneficial drug  Opportunity to contribute to the advancement of science  Possible need to travel a further distance for your cancer treatment  Possibility of receiving a new drug that provides no additional benefit but may add side effects  Additional visits to the clinic and laboratory procedures

 Patients who reflect the diversity of people affected by breast cancer  Patients who understand the pros and cons of being in a clinical trial  Patients who are comfortable with neoadjuvant treatment  Patients who understand and are likely to comply with the incremental research procedures that will be required by I-SPY2 participants  Patients who understand the investigational nature of incremental drugs 5

 Patients who want to do whatever their clinician suggests, whether or not they understand  Patients who are so emotionally and/or cognitively distressed as to be unable to adequately understand the consequences of participating in a clinical trial 6

◦ From NCI: al-trials-education-series al-trials-education-series ◦ From Dana Farber: info/default.html info/default.html ◦ From ACS: 6_3_Clinical_Trials_-_Patient_Participation.asp 6_3_Clinical_Trials_-_Patient_Participation.asp

 Why do patients participate in clinical trials?  Overview of I-SPY2: Interacting with patients  Helping patients decide whether or not to participate in the I-SPY2 clinical trial  Patient support materials and services  Recruitment & Retention Plan 

The purpose of I-SPY2 is to learn:  If patients with breast cancer benefit from adding an investigational agent to their standard chemotherapy before surgery  What effects, good and bad, the combination of therapy has on your cancer  What changes this combination of drugs has on your tumor through Magnetic Resonance Imaging Clinical Trials are the way to advance our understanding of cancer and find better treatments!

Recruit Patients Enroll Patients Treat Patients

I-SPY 2 Brochure Make Patients Aware of Trial Screening Consent Discussion Interest ? Done Yes No I-SPY 2 Patient Website, DVD

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

 Helping patients decide whether or not to participate in the I-SPY2 clinical trial  Unusual features of the I-SPY2 consenting process  Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients  Individualizing the Consent Process  Anticipating and Answering Patient Questions about I-SPY2  Role Play 

 They will receive their chemotherapy prior to surgery (neoadjuvant treatment)  Their surgery will take place in approximately six months.  Chemotherapy will include standard drugs (Taxol, AC, and Herceptin in HER2+). Additionally patients will be randomized to receive on of many investigational drugs, or no additional drugs (~20%)  If a patient is randomized to receive an investigational drug, it will be selected because it is expected to work for their type of cancer  There will be 3 more biopsies and 3 extra MRIs that would not be required if they were not in the trial  Research drugs and procedures will be paid for by trial sponsors, but patients or their insurers will be responsible for standard treatment

Screening Consent Patient not on study Not considered good candidate for chemotherapy Patient not on study Not considered good candidate for chemotherapy Treatment Consent Patient On Study Randomized to treatment arm based on stratifying biomarkers Treatment Consent Patient On Study Randomized to treatment arm based on stratifying biomarkers No Yes Is patient eligible?

 Newly diagnosed patients with stage II or III breast cancer  > 2.5cm tumor  Biomarkers profile that indicates that you are at a high risk of recurrence with standard treatment—based on: ◦ ER/PR ◦ Her2 ◦ MammaPrint

 Provides general description of I-SPY2 ◦ Goals ◦ Patient Schedule ◦ Risks and Benefits ◦ Financial Issues  Does not provide specific information about drugs  Provides specific information about eligibility requirements and screening procedure  Requests patients’ agreement to be screened

 Follows patient randomization  Provides detailed description of I-SPY2 ◦ Goals ◦ Patient Schedule Specific drug side effects ◦ Risks and benefits ◦ Financial issues ◦ Withdrawal process  Requests patients’ agreement to be treated in I-SPY2

 Thank her for consider the trial  Solicit her concerns ◦ Start open ended question ◦ Then cue her with the categories on the Transcend screen (see next slide) ◦ Try to drill down to get understand specifics  Capture information on the CRF  Ask patient to complete the pre-stamped and addressed “Patient Decline Questionnaire”

 Also, ask her if she would be willing to fill out an anonymous questionnaire describing her concerns ◦ If yes—give her some private time to do so ◦ If not—ask her to take home the questionnaire and consider completing later in the week, and dropping it in the mail

Did patient sign Consent?  Yes  No – reasons why not (check all that apply)  Patient was found to be ineligible  Patient decided against being in any trial  Treatment Concerns  Neodjuvant therapy  AC  Investigational drug  Too many biopsies  Too many MRIs  Insurance and/or financial Concerns  Logistic concerns  Too many extra clinic visits  Too far from home  Wants to be treated by local doctor  Family and/or job issues  Other

 Not being eligible is not a bad thing  It just means that your tumor type is not matched to the investigational drugs  Your tumor is likely to respond well to standard treatment alone  However you may want to participate in a different clinical trial  We will maintain a list of potential trials, using

 Helping patients decide whether or not to participate in the I-SPY2 clinical trial  Unusual features of the consenting process  Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients  Individualizing the Consent Process  Anticipating and Answering Patient Questions about I-SPY2  Role Play 

 You’ve just been diagnosed with cancer  You don’t know much about cancer, but you assume it’s a death sentence  You don’t know much about cancer treatment, but you believe it will make you very sick and bald  You are not familiar with the hospital, but and being in it makes you very uncomfortable

 You are already close to the edge due to: ◦ Family challenges -- spouse, kids, aging parents ◦ Financial challenges ◦ Work issues  How can you get through this?  Can you just give up?  Are you dreaming? No, but this will interfere with your sleep for some time to come, and likely change the rest of your life, no mater how long that is!

Are All the SameEach is Unique  Overwhelmed  Emotional traumatized  Cognitively compromised  Understanding of cancer treatment and treatment trials  Information needs, cognitive style  Methods of coping  Family and financial situation  Age, ethnicity, job status

 Validate patients emotions  Slow down  Engage others  Ask about patients emotional state, needs, feelings  Ask about patients cognitive state, needs, preferences  Require patient to paraphrase, using their own words  Continually solicit feedback and questions from patients and adjust accordingly  Use multiple formats—words, pictures, diagrams, models  Give patient take away material and follow-up phone numbers

Improving the Consent Discussion  Getting Starting Prepare yourself for the meeting, including emotionally 5 questions to ask your patient Empathize with the patient’s predicament Close with discussion of “next steps” Provide patient with “take-homes Ask the patient to explain the situation Build on what the patient has told you Ask the patient about her questions & concerns Respond to each of the patients issues, one by one Have the patient paraphrase your responses to ensure understanding Raise critical issues that the patient has not raised Adapted from CISN ( ClosingPatient Interaction

 Helping patients decide whether or not to participate in the I-SPY2 clinical trial  Unusual features of the I-SPY2 consenting process  Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients  Individualizing the Consent Process  Anticipating and Answering Patient Questions about I-SPY2  Role Play 

1. How much does this patient already understand about her condition and options? 2. How much does this patient want to know about her condition and options? (e.g., Is she a “blinder” or “monitor?) 3. What are the issues that will be most important to this patient? 4. What are the best ways to help this patient understand what she wants/needs to understand? 5. What additional support can I offer to this patient? Adapted from CISN (

1. How much does this patient already understand about her condition and options?  Start by asking the patient to explain how she understand her diagnosis and treatment options  Depending on her answer, cover the topics she needs, in the following order: ◦ Her diagnosis ◦ Standard of care ◦ What a clinical trial is ◦ How participating in I-SPY2 would be different from standard of care

2. How much does this patient want to know about her condition and options?  Some patients want to know everything, including statistics ◦ Cover key concepts first, but let them know how to access more information  Some patients do not want much information ◦ Go over the most critical concepts only  Some patients do not want to know anything; they want their doctor to decide ◦ The decision needs to be the patient, and be based on understanding their options ◦ You must be sure they understand the pros and cons of participating in I-SPY2

3. What are the issues that will be of most important to this patient?  Survival  Getting through treatment—e.g., side effects  Family issues  Job issues  Logistics, travel  Insurance and/or other financial concerns  Complementary and/or alternative treatments  Other

4. What are the best ways to help this patient understand what she wants/needs to understand?  Be sensitive to the patient’s culture  Involve a significant other or translator  Use analogies and metaphors  Provide or avoid mentioning statistics  Providing pictures, flow charts, plus/minus table (see )  Providing take homes (e.g., brochures, DVD)  Other

5. What additional support can I offer to this patient?  Psychology referral  Social worker referral  Patient navigator referral  Clergy referral  Access to another patients  Local support groups  Other See

 Helping patients decide whether or not to participate in the I-SPY2 clinical trial  Unusual features of the I-SPY2 consenting process  Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients  Individualizing the Consent Process  Anticipating and Answering Patient Questions about I-SPY2  Role Play 

IssuePotential Resolution  Neoadjuvant treatment—postponing surgery  Chemo side effects  Taking an investigational drug  The particular investigational drug  Not receiving an investigational drug  Extra MRIs and/or biopsies  Other       See

IssuePotential Resolution  Mortality  Family issues  Job issues  Insurance concerns  Time, cost, additional inconvenience of extra clinic visits  Distance to trial site  Change of doctor  Other      

 Helping patients decide whether or not to participate in the I-SPY2 clinical trial  Unusual features of the I-SPY2 consenting process  Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients  Individualizing the Consent Process  Anticipating and Answering Patient Questions about I-SPY2  Role Play 

 Divide into groups of three  Assign roles ◦ Patient ◦ Heath care provider ◦ Observer  Role play for ~6 minutes  Debrief with each team member discussing their feelings and observations  Time permitting, rotate roles and scenarios ‣ Select a scenario o Screening consent o Non-eligible discussion o Treatment consent

 Why do patients participate in clinical trials?  Overview of I-SPY2  Helping patients decide whether or not to participate in the I-SPY2 clinical trial  Patient support materials and services  Recruitment & Retention Plan 

 Introductory brochure  Patient DVD  User friendly I-SPY2 Patient Website ( )  Location specific support (can be found at )

 24x7 toll free hotline ( )  Staffed by trained and certified breast cancer survivors  Free to all callers  Spanish speaking counselors  Interpretation available in over 150 languages  option  Match programs ◦ Patient specific requests (e.g., diagnosis, treatment, demographics) ◦ Male breast cancer matches ◦ Partner’s match program

 A select group of experienced peer counselors will be specifically trained about I- SPY2 (primarily based on )  One of the counselors will be Spanish speaking  Once assigned to a patient, the counselor will periodically (approximately once a month) call to check on patient

 Provide participants with an opportunity to discuss their diagnosis and treatment issues with trained peer counselors: ◦ Validation of emotions and support for dealing with them ◦ Questions about treatment or trial  Help patients anticipate next steps in treatment  Encourage participants to comply with trial requirements and raise concerns with their health care provider

 During the treatment consent, patients will be provided with “Network of Strength Counselor Request” ◦ If a patient fills out and returns the self- addressed/pre stamped form, she will be assigned an I-SPY2 Peer Counselor ◦ Patients who do not wish a specially assigned counselor may still call the hotline ( ) any time (24x7)

Name: Address: Nancy L. Nixon Director--Contact Center Breast Cancer Network of Strength(r) 300 W. Adams St., Suite 430 Chicago, IL 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 hotline ( ) 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. Patient’s Name: Preferred Phone Number: Call Time Preferences: Trial Site: Enrollment Date” Biomarker Profile: Treatment Arm: To be completed by Network of Strength Staff Network of Strength Counselor: Assignment Date:

For all calls: 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 - Shortly After Enrolled After Completion of Taxol Prior to Surgery After First Treatment Following Surgery

 Why do patients participate in clinical trials?  Overview of I-SPY2  Helping patients decide whether or not to participate in the I-SPY2 clinical trial  Patient support materials and services  Recruitment & Retention Plan 

 The single largest reason for patients NOT participating in clinical trials is that they were not ASKED ◦ Local surgeons/oncologists will be key to making patients aware of the opportunity to participate in I-SPY2 ◦ Make sure local and referring surgeons/oncologists are aware of I-SPY 2 and have access to patient support materials ◦ Identify their objections and help us remedy them

 Ensure that I-SPY2 participants reflect the diversity of people diagnosed with breast cancer  Ensure patients who are enrolled in I-SPY2 have adequate emotional support, so they comply with all requirements and complete the trial

 Goal: Summing over trial sites, I-SPY2 patients should reflect the diversity of US women affected by breast cancer  Actions: ◦ Travel reimbursement for research visits ◦ Proactive recruitment of trial sites that over represent minorities ◦ Identify potential affiliate and/or satellite hospitals that might partner with main I-SPY2 sites ◦ Proactive recruitment of patients from under represented minorities  Targeted advocacy organizations (e.g., ICC)  Targeted community outreach  Targeted publications

 Actions Continued: ◦ Develop and deliver culturally sensitive and targeted workshops on participation in clinical trials in general and I-SPY2 in particular ◦ Ensure that all of our patient materials are culturally sensitive and include pictures that reflect diverse populations ◦ Translate the Informed Consent and Recruiting Brochure into Spanish and/or other languages ◦ Identify language translation services that are available at each site ◦ Identify potential affiliate and/or satellite hospitals that might partner with main I-SPY2 sites

 Quarterly by Trial Site ◦ Which sites are exceeding expectations? What can we learn from them? ◦ Which sites are failing to meet expectations? How can we remedy this?  Quarterly by Patient Biomarker Profile and Treatment Plan  Bi-annually for adequate diversity

ProblemPotential Solution Too few patients are offered trial  Educate clinicians at trial sites  Recruit more trial sites  Increase national publicity Too many patients decline screening consent  Educate consenters  Improve patient material  Assess reasons for decline Too many patients decline treatment consent  Educate consenters  Improve patient material  Assess reasons for decline  Look for variation by treatment arm

ProblemPotential Solution Distribution of patients by biomarker profile does not reflect distribution in populationV  Identify competing trials for specific profiles at specific sites  Over recruit from other sites Distribution of patients declining treatment varies by treatment assignment  Clarify whether the issue is based on rejecting standard of care or a particular investigational agent  Consider over recruiting controls and/or dropping problematic investigational agents Inadequate diversity  Recruit sites in more diverse communities  Increase targeted promotion

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

 I-SPY2 patient brochure  I-SPY2 patient DVD  I-SPY2 Patient Decline Mailer  Network of Strength Peer Counselor Request Mailer