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

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i spy2 recruitment retention plan

I-SPY2 Recruitment & Retention Plan

Draft -- September, 2009

recruitment retention interface
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

table of contents
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
promotion
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
i spy2 brochure
I-SPY2 Brochure
  • See draft brochure
consenting patients
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
diversity considerations
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
diversity considerations1
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
tracking
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
decline questionnaire
Decline Questionnaire
  • See draft Decline Questionnaire
table of contents1
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
patient materials
Patient Materials
  • Recruiting Brochure
  • New Patient Portfolio
  • Website PDFs
    • Fact Sheets
    • Patient Schedule
    • Trial Site Map, Support Services, Contact Information
  • Peer to Peer Letters
patient website requirements
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
i spy2 patient website
I-SPY2 Patient Website
  • See Prototype
  • http://gemini-grp.com/ISPYPatientindex.htm
network of strength hotline formerly y me
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
i spy2 use of network of strength hotline
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
site specific support
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
follow up
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
follow up continued
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
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