Division of Cancer Prevention
Recruitment Retention and Adherence Plan Template
Instructions:
NCI DCP requires a study-specific recruitment, retention and adherence (RRA) plan for each cancer chemoprevention study. This template is intended to assist investigators and RRA coordinators in developing a study-specific RRA plan, by providing prompts based on four phases: 1) planning, 2) recruitment, 3) retention and adherence, and 4) evaluation.
Bold font indicates the required components of an RRA plan.
A. Planning Phase - Prior to Study Initiation Meeting
a. Determine staff assignments:
i. Identify RRA coordinator for the study
ii. Identify alternate recruiters to provide assistance and/or back-up
iii. Outline role of the Principle Investigator (PI):
1. Determine involvement with participants, e.g., Will they meet with and/or consent every participant? Will they see participant every visit?
2. Assure PI’s availability to the RRA coordinator
3. Give appropriate decision-making authority to the RRA coordinator
4. Monitor recruitment
5. Meet with staff regularly
iv. Designate consistent staff contacts for participants (e.g., coordinator, PI, receptionist)
b. Determine the impact of protocol design on recruitment efforts
i. Evaluate feasibility of planned sample size
1. Availability of target population considering demographics
2. Availability of target population considering eligibility criteria
3. Possible effects of placebo control arm
ii. Determine possible effects of participant access to FDA-approved studies
1. Possible effects of potential toxicity profile
2. Possible effects of complicated entry criteria and/or burdensome protocol procedures
iii. Estimate availability of eligible participants based on
1. Consultation with potential participants
2. Review of patient lists associated with each site
3. Review of literature
4. Calculate number of eligible enrolled participants versus number of eligible participants who chose not to enroll in previous studies at site
5. Estimate accrual rate (# of participants per month)
iv. Consider areas for protocol modification (if recruitment goal proves to be unrealistic)
1. Broadening eligibility criteria (e.g. time frames for completion of tests and procedures, lab values)
2. Simplifying protocol
3. Decreasing sample size
4. Extending recruitment period
c. Outline Plan to Identify and Contact Known and Potential Referral Sources
i. Survey potential referring physicians, obtain letter of commitment if possible
1. Cultivate working relationship with specialists who focus on diseases related to the study’s target organ (e.g. surgeons, gynecologists, gastroenterologists, pulmonologists)
ii. Enlist endorsement and cooperation from non-physician referrals, such as:
1. Community centers (may be associated with religious or ethnic groups)
2. Retirement communities
3. Senior centers
4. YMCAs and public libraries
5. Health clubs
6. Churches
7. Local corporations
8. Alliances with disease specific organizations:
a. Patient advocacy groups
b. Support groups
c. Charitable organizations
d. Determine Metrics to be Used for Evaluation of RRA Performance
i. Plan for quick recognition of lagging enrollment
1. Create and document enrollment timeline with milestones and evaluation points
2. Plan to monitor and document the timeliness of task completion at each site
a. Regulatory requirements
b. Weekly meetings
ii. Plan to evaluate and document strategies and associated outcomes
1. Track number of participants enrolled in defined time periods associated with each strategy
2. Create screening/enrollment log forms showing attribution to specific recruitment strategies and reasons for ineligibility or non-enrollment as applicable
3. Calculate cost of enrollment per participant
4. Maintain and monitor screening/enrollment logs
5. Survey participants’ opinions: strengths and weaknesses of strategies
iii. Plan to track participant withdrawals and reasons for withdrawal
e. Outline Plan To Train Staff in Recruitment
i. Educate staff regarding recruitment and protocol specifics (after protocol is approved)
ii. Develop and distribute protocol summary pocket cards or electronic equivalent
iii. Develop Frequently Asked Questions (FAQ) document
iv. Train support staff
1. Hospitality and smooth clinic flow
2. Procedural requirements (e.g. fasting)
3. Procedures to follow when there are protocol violations
v. Prepare script to explain protocol to participants
f. Outline Plan to Promote a Comfortable and Pleasant Clinic Environment/Experience
i. Supply driving directions
ii. Coordinate well organized clinic flow
iii. Assure user-friendly test scheduling, drug dispensing, etc.
iv. Negotiate, and to the extent possible, insist upon flexible times and days of the week when study participants may be seen in clinic
v. Plan to allow ample time for participants with staff
vi. Schedule periodic meetings between clinic coordinator and staff to discuss issues of scheduling, flow, etc
g. Outline Budget for RRA
i. Staff
ii. Recruiter transportation to community outreach events
iii. Participant compensation
iv. Recruitment and retention strategies (see Section h below)
h. Outline Recruitment Strategies (Remember to adhere to local IRB requirements as to whether or not IRB approval is required for these strategies)
i. General strategies:
1. Regular contact with referral sources
2. Advertisements
a. Newspaper
b. TV
c. Radio
d. Internet social networking sites such as Twitter and Facebook
e. Direct mailings
f. Posted flyers
3. Public Relations
a. Investigator interviews
b. Patient education lectures
c. Educational sessions by Investigator or RRA coordinator to relevant community organizations
d. FAQ document
e. Mass media and press releases
f. Regular posts to social networking sites
4. Partner with other studies
5. Identify spokespersons
ii. Minority recruitment strategies
1. Perform or utilize available cultural assessment of local community
2. Consider centralized minority coordinator
3. Consider matched ethnicity recruitment coordinator
4. Have translator available
5. Identify minority community liaison
6. Meet with minority community leaders
7. Attend community meetings
8. Establish relationships with community churches
iii. Special needs participant strategies
1. Large print documents
2. Transportation assistance
3. Interpreters
iv. Support for recruiters/consortium staff
1. Newsletter within consortium
2. Teleconferences within consortium
3. Recognition of high recruiters (within consortium or institution)
4. Frequent contact with participating site coordinator(s)
B. Recruitment Phase
a. Implement strategies selected during planning phase
b. Assess eligibility of individual potential participants
i. Begin supportive relationship with participant
ii. Consider non-compliance and retention potential
1. Exclude participants unlikely to comply and stay on study – unless you can provide compensatory support and follow-up
2. Known history of non-compliance
a. Socially unstable
b. Expressed difficulty with, and numerous objections to, protocol requirements
c. Cavalier attitude toward protocol
d. Verbalized a minimization of cancer risk
e. Verbalized a desire for “active drug only”
c. Explore individual participant’s objections to enrollment
i. Clarify any misconceptions
ii. Work to resolve manageable logistical problems
iii. Consider multiple objections as red flag indicating possible retention/compliance problems
iv. Involve participant’s support system in decision-making
d. Continuously evaluate strategies as planned during pre-initiation phase
i. Monitor and document task completion in a timely way
1. Regulatory requirements
2. Weekly meetings
3. Meeting minutes
ii. Document evaluation of strategies and outcomes as planned
1. Track results of each strategy
2. Maintain screening/enrollment log forms
3. Calculate cost of enrollment per participant
4. Survey participants’ opinions: strengths and weaknesses of strategies
iii. Rapidly implement modified or alternative plans if recruitment is lagging
C. Retention and Adherence Phase – Be Proactive
a. Maintain communication with referring physicians in regard to participant progress
b. Establish and maintain rapport among staff
i. Newsletter
ii. All-site teleconferences
iii. Adequate staff compensation
iv. Staff recognition/awards
v. Non-protocol staff recognition, e.g., clinic, support staff
c. Establish and maintain rapport and communication with participants
i. Identify red flags for possible attrition
1. Adverse Events
2. Missed appointments
3. Frequent appointment time changes
4. Report of major personal or family events
5. Health deterioration
6. Loss of support system
7. Do not promise support that cannot be maintained
ii. Adverse event (AEs)
1. Inform participants as to what to expect
2. Have prepared AE management protocol
iii. Maintain current info
iv. Enlist support of participant’s social support system
1. Transportation
2. Encouragement
3. Agent compliance
v. Provide compensation for expenses incurred as budget permits
1. Parking
2. Time lost from work
3. Transportation
4. Child care
vi. Ensure pleasant visits
1. Limit waiting room time
2. Coordinate assessments (e.g., blood work, imaging, etc.) with visits
3. Provide refreshments
4. Be flexible with scheduling while staying within visit windows
5. Provide toll-free numbers for the clinic as needed.
vii. Ensure consistent staff contact person and access to PI
viii. Establish schedule for contact with participant
ix. Consider retention tools
1. Calendars
2. Newsletter
3. Appointment reminder calls, cards, and e-mails
4. Anniversary cards
5. Certificates of appreciation
6. T-shirts, mugs, magnets
7. Support groups
x. Track participant withdrawals and reasons for withdrawal
D. Evaluation Phase
a. Review study recruitment and adherence data from all tracking documents
b. Discuss lessons learned with team
c. Document lessons learned
d. Consider submitting manuscripts for publication
i. Successful strategies
ii. Lessons learned
e. Plan to apply knowledge gained to next study recruitment efforts
Version 4 4
Version Date: August 5, 2013