I-SPY2 Recruitment & Retention Plan

1. I-SPY2 Recruitment & Retention Plan Draft -- September, 2009

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

3. Table of Contents • 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

4. Promotion • 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

5. I-SPY2 Brochure • See draft brochure

6. Consenting Patients • 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

7. Overall Recruitment Expectations

8. Diversity Considerations • 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

9. Diversity Considerations • 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

10. Accrual by EEO Category(Assumes Discount Factor = 35%)

11. Tracking • 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

12. Rapidly Diagnosing & Remedying Accrual Problems:Number of Patients

13. Rapidly Diagnosing & Remedying Accrual Problems: Distribution of Patients

14. Quarterly Tracking By Trial Site(Assumes Discount Factor of 35%

15. Quarterly Tracking By Biomarker Profile

16. Quarterly Tracking By Treatment

17. Bi-annual Diversity Tracking

18. Decline Questionnaire • See draft Decline Questionnaire

19. Table of Contents • 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

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

21. Patient Website Requirements • The right amount of the right information at the right time • Easy to navigate • Attractive—white space, pictures • Text and FAQs • PDF of key pages for use by trial site staff

22. I-SPY2 Patient Website • See Prototype • http://gemini-grp.com/ISPYPatientindex.htm

23. Network of Strength Hotline (formerly Y-ME) • 24x7 toll free hotline • Staffed by trained and certified breast cancer survivors • Free to callers • Spanish speaking counselors • Interpretation available in over 150 languages • E-mail option • Match programs • Patient specific requests (e.g., diagnosis, treatment, demographics) • Male breast cancer matches • Partner’s match program

24. I-SPY2 Use of Network of Strength Hotline • 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

25. Site Specific Support • 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

26. Follow-up • 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

27. Follow-up (continued) • 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