Draft -- September, 2009

Randomize Agree? Make Patients Aware of Trial Enroll & Start Treatment Screening Consent Discussion Interest ? Eligible? Agree? Done Treatment Consent Discussion Yes No Yes No Yes No Non-Eligibility Letter Decline Questionnaire I-SPY2 Patient Portfolio Decline Questionnaire Optional Peer Support Call Peer Support Call (s) Done? Congratu- tions Letter No Yes Welcome Letter I-SPY2 Brochure Exit Interview Dropped Out No I-SPY2 Patient Website

Recruitment Promotion Consenting Patients Overall Recruitment Expectations Diversity Considerations Tracking Accrual Patient Decline Questionnaire Retention Patient Materials/Website Network of Strength Hotline Site Specific Support Exit Questionnaire

Trial Site Education Sessions, especially with surgeons Advocacy and Clinical Trials Websites Educational Sessions and Materials for Breast Cancer Hotlines National Scientific and Advocacy Education Sessions Local and National Press Release Local and National Press, TV, & Radio Interviews Local and National Advocate Presentations Scientific and Patient Publications Broad Distribution of I-SPY2 Brochure

See draft brochure

Informed Consent documents have undergone careful review by a large number of experienced advocates Training will be developed to reinforce best practices in consenting and summarize I-SPY2 specific information FAQ questions will be made available to consenters Patient website will have fact sheets, patient schedules, and other relevant information available as PDFs to support consenting process

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 population 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

See draft Decline Questionnaire

Recruitment Promotion Consenting Patients Overall Recruitment Expectations Diversity Considerations Tracking Patient Decline Questionnaire Retention Patient Materials/Website Network of Strength Hotline Site Specific Support Exit Questionnaire

Recruiting Brochure New Patient Portfolio Website PDFs Fact Sheets Patient Schedule Trial Site Map, Support Services, Contact Information Peer to Peer Letters

The right amount of the right information at the right time Easy to navigate Attractivewhite space, pictures Text and FAQs PDF of key pages for use by trial site staff

See Prototype

24x7 toll free hotline Staffed by trained and certified breast cancer survivors Free to 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 Partners match program

Screening and Treatment Informed Consent Forms request permission for Network of Strength counselor to call patient Patient may, alternatively, take number and call if and when they please A select group of experiences counselors will be specifically trained about I-SPY2 (based on I-SPY2 Website) Supporting, but not pressuring patients, who are considering enrollment Checking in on, encouraging, and supporting patients who are undergoing treatment

Website will provide site specific information Maps Hospital investigators and contact information Hospital services and contact information Locally available advocacy and support groups Encourage all sites to maintain regular communication with patients and continuous express appreciation for participations in I- SPY2 Optionally, local advocates will be identified to work with investigators at specific trial sites

Finalized Recruiting Brochure Develop detailed PR plan and pieces Develop training for consenters Reassess accrual assumptions Obtain site-specific recruitment, accrual, and diversity expectations Finalize tracking reports and data collection plan Finalize data collection and analysis plans for patient declines

Ensure conformance of Informed Consent documents and plan Hot-line support Decline questionnaire Follow-up on Patient Website Finalize material Construct site Pilot test with advocates Follow-up on Hot-line Finalize budget Negotiate terms Select counselors Develop and deliver training Develop Site Specific Support information