Abstract
OBJECTIVE: Fear of cancer recurrence (FCR) is common, persistent, and associated with lower quality of life, impaired functioning, and psychological distress in family caregivers (FC) of individuals with a cancer diagnosis. Interventions are needed to specifically target FCR in FC. This study aimed to pilot test the adapted Family Caregiver-Fear Of Recurrence Therapy (FC-FORT) to establish its feasibility, acceptability, and clinical significance. METHODS: This pilot study used a mixed-method, parallel, two-group randomized control trial (FC-FORT vs. waitlist control group) design. Women FC were recruited through Canadian hospitals, community partners, and social media. FC in the intervention group completed 7 weekly sessions of virtual group therapy (FC-FORT) and an exit interview. All participants completed questionnaires at baseline, post-intervention, and 3-month follow-up. Feasibility (e.g., recruitment, allocation, fidelity), acceptability (e.g., dropout, completion, satisfaction) and clinical significance of secondary outcomes were evaluated. Descriptive statistics, mixed ANOVAs, and conventional content analyses were used. RESULTS: Regarding feasibility, 22 FC were recruited, 18 were randomized and therapist fidelity was 87%. As to acceptability, 67% of participants completed ≥ 5 sessions (33% dropout). Questionnaire completion rate was 92%. FC satisfaction was 80%. Analyses did not reveal any significant differences on the secondary outcomes between groups. Qualitative analyses revealed high importance, helpfulness, satisfaction, and group cohesion. Suggestions were made by FC for improvements. CONCLUSIONS: This is one of the first interventions to address FCR in FC. While acceptability of FC-FORT was good, important feasibility issues need to be addressed before moving forward with a larger randomized control trial. TRIAL REGISTRATION: NCT, NCT05441384. Registered July 1st, 2022, https://classic. CLINICALTRIALS: gov/ct2/show/NCT05441384.