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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


Make Patients Aware of Trial

I-SPY2 Brochure




Treatment Consent Discussion

I-SPY2 Patient Website


Screening Consent Discussion



Decline Questionnaire

I-SPY2 Patient Website


I-SPY2 Patient Website

Enroll &Start Treatment

Optional Peer Support Call

I-SPY2 Patient Portfolio

Welcome Letter



Decline Questionnaire

Peer Support Call (s)








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


  • 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

Accrual by eeo category assumes discount factor 35
Accrual by EEO Category(Assumes Discount Factor = 35%)


  • 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

Quarterly tracking by trial site assumes discount factor of 35
Quarterly Tracking By Trial Site(Assumes Discount Factor of 35%

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

  • 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