IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors
Phase: NA
Conditions: Cancer, Coping Skills, Coping Behavior
Sponsor: Massachusetts General Hospital

 
 
 
 
 
 
 
 
Mind-Body Resiliency Intervention for Fear of Cancer Recurrence 
NCT04876599 
Prepared 8/18/2023 
 
 

Synopsis of Protocol 
 
Preparation (approximately 4-6 months) 
 
• 
Submission of protocol to Dana-Farber/Harvard Cancer Center IRB (MGH and BIDMC cancer centers 
are part of the DF/HCC) 
• 
Finalization of all materials, including electronic surveys (REDCap) and exit interview guide 
• 
Training of the interventionist on the adapted intervention (see Study Team Structure) 
• 
Registration on clinicaltrials.gov 
 
Recruitment (approximately 4 months) 
• 
Participant recruitment (see Recruitment and Retention Plans) 
 
Intervention, exit interviews, and three survey assessments (26 months): The total length of participation 
for each enrolled subject will be approximately 5 months. Mind-body groups are anticipated to last 8 weeks (2 
months), which is the duration of the original Relaxation Response Resiliency Program (3RP); however, this 
will be informed by the earlier intervention refinement phase from the Aim 1 study. A timeline for the pilot RCT 
(N=64) is presented below. 
 
• 
A baseline assessment (T1) consisting of a survey with 
proposed self-report measures. We will also conduct a 
chart review to measure indices of healthcare 
engagement (see Outcome Measures, Section 4.3) 
 
• 
Randomization to either 8-week arm (full descriptions in 
Narrative Study Description, 4.2.a) 
o (1) adapted group mind-body intervention, or  
o (2) treatment as usual (referral for cancer support 
group through SurvivorJourneys) 
 
• 
Post-intervention assessment (T2) consisting of the 
survey, our chart review of healthcare engagement, and 
an exit interview 
o Exit interviews will take place within 1 week post-
intervention (see Research Strategy, Measures, 
Aim 2 Primary Outcomes) 
 
• 
3-month follow-up assessment (T3) consisting of the 
survey and our chart review of healthcare engagement 
 
Analysis and reporting of primary outcomes (feasibility and acceptability) and exploratory outcomes 
(12 months) 
• 
Cleaning of survey data 
• 
Transcription of exit interviews 
• 
Quantitative analyses (see Section 4.4., Statistical Design and Power) 
• 
Qualitative analyses (see Section 4.4., Statistical Design and Power) 
• 
Report of findings on clinicaltrials.gov 
• 
Manuscript and grant preparation (see Research Strategy, Table 3: Planned Deliverables)