Randomize
Agree?
Make Patients Aware of
Trial
Enroll &Start
Treatment
Screening Consent
Discussion
Interest?
Eligible?
Agree?
Done
Treatment Consent
Discussion
Yes
Yes
No
Yes
No
Yes
No
Non-Eligibility
Letter
Decline Questionnair
e
I-SPY2 Patient
Portfolio
Decline Questionnair
e
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
I-SPY2 Patient Website
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
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
ExpectationsWorst Case
Scenario
Best Case
Scenario
Other Scenario
Expected Number of Potential Patients Per Month
10 30
Expected Percent of Patients Who are Offered Trial per Month
40% 80%
Expected Percent of Patients Offered Who Accept Screening
50% 80%
Expected Percent of Screened Patients Who are Eligible
70% 90%
Expected Percent of Eligible Patients Who Accept Treatment Trial
50% 80%
Expected Discount Factor 7.0% 46.1% 0.0%Expected Number of Patients Accrued per Month
0.7 13.8 0.0
Total Months to Accrue 800 Patients 1142.86 57.87 #DIV/0!
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
Trial SiteExpected Treated
Per Month
Expected Acrued to Trial Per Month
% Cauca-
sian
% African Ameri-
can
% Hispan-
ic
% Asian
% Other
% Older than 70
Emory University 0.0
INOVA Health System 0.0
Kansas U Medical Center 0.0
Mayo Clinic 0.0
MD Anderson 0.0
UC at San Diego 0.0
UC at San Francisco 0.0
U of Arizona 0.0
U of Chicago 0.0
U of Colorado 0.0
U of Minnesota 0.0
U of Pennsylvania 0.0
U of Texas Southwestern 0.0Other 0.0
0.00.00.0
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
Problem Potential 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
Problem Potential SolutionDistribution 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
Trial Site
Expected Treated
per Quarter
Actual Treated
Last Quarter
Expected Acrued to Trial
Per Quarter
Actual Accrued
Last Quarter
Treated - Accrued
Last Quarter
Number of
Decline Question
naires Last
Quarter
Not Offered
Last Quarter
Emory University 0.0 0 0INOVA Health System 0.0 0 0Kansas U Medical Center 0.0 0 0Mayo Clinic 0.0 0 0MD Anderson 0.0 0 0UC at San Diego 0.0 0 0UC at San Francisco 0.0 0 0U of Arizona 0.0 0 0U of Chicago 0.0 0 0U of Colorado 0.0 0 0U of Minnesota 0.0 0 0U of Pennsylvania 0.0 0 0U of Texas Southwestern 0.0 0 0Other 0.0 0 0
0.0 0 0
HR+ HR- HR+ HR-Her2+ Expected 16.0% 7.0% 4.0% 10.0%
ActualHer2- Expected 23.0% 6.0% 6.0% 28.0%
Actual
Hi-MP2Hi-MP1
Treatment
# of Randomized
Patients Assigned to Treatment
# of Randomized
Patients Accrued to Treatment
Decline Rate
Standard of Care #DIV/0!Agent A #DIV/0!Agent B #DIV/0!Agent C #DIV/0!Agent D #DIV/0!Agent E #DIV/0!Agent F #DIV/0!Agent G #DIV/0!Agent H #DIV/0!
#DIV/0!Total 0 0 #DIV/0!
Cauca-sian
African American
Hispanic Asian OtherOlder
than 70Expected Treated Per Six MonthsActual Treated in Last Six MonthsDifferenceExpected Acrued Per Six MonthsActual Acrued in Last Six MonthsDifference% of Last Six Month Accrual% US Breast Cancer PatientsDifference
See draft Decline QuestionnaireFactor Major
Concern Minor
Concern Not a
Concern
I want to have my surgery as soon as possible, rather than having chemo first.
I did not want to take any drugs that haven’t been fully tested
I do not want to have any treatment that includes Anthrecycline
I do not want my treatment decided by randomization
I do not want to have multiple MRIs
I do not want to have multiple needle biopsies
The trial site is too inconvenient
I do not want to have to make extra trips to the clinic
I do not want to change doctors
I am concerned about what my insurance will pay
I am concerned about possible financial consequences associated with being the this trial
I am concerned about possibly loss of privacy
I do not want to be a guinea pig
Other (please specific)
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 Attractive—white space, pictures Text and FAQs PDF of key pages for use by trial site
staff
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
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