Fear of cancer recurrence (FCR) is prevalent and distressing among survivors of cancer. Evidence-based mind-body and cognitive-behavioral skills lack integration and testing in scalable formats. This pilot randomized controlled trial (NCT04876599) tested a synchronous, virtual mind-body group resiliency intervention for FCR (IN FOCUS). Adults with elevated FCR (FCR Inventory severity ≥ 16; 16-21=elevated, 22-36=clinically elevated) after completing primary treatment for non-metastatic cancer were randomly assigned (1:1) to eight weekly sessions of IN FOCUS or usual care (UC; synchronous, virtual community group support referral). Feasibility metrics included ≥ 70% retention per arm (primary outcome), ≥ 75% attendance in ≥ 6 sessions, ≥ 75% adherence to relaxation skills practice ≥ 3days per week and by delivery fidelity (% content covered in video-recorded sessions). Acceptability was assessed quantitatively via ratings of enjoyableness, convenience, helpfulness, odds of future use, and satisfaction (benchmark ≥ 80% of ratings ≥ 4 on 1-5 Likert scale) and qualitatively via individual exit interviews. Linear mixed models explicated slopes in FCR (secondary) and resiliency (exploratory; Current Experiences Scale) from baseline to 2months (primary endpoint) and 5months using intention-to-treat. From July 2021 to March 2022, 64 survivors enrolled (25-73years old, M=7years since diagnosis). IN FOCUS was feasible and acceptable (91% retention; attendance median=7 sessions, 97% relaxation practice adherence, 95% content fully covered; 82% of acceptability ratings ≥ 4). Interviews (n=59) revealed benefits in both arms. By 2months, compared to UC, IN FOCUS reduced FCR to a medium-to-large effect (Mdiff=-2.4; 95% CI=-4.2, -0.7; d=0.66). By 5months, FCR effects had attenuated (Mdiff=-0.16, 95% CI -1.97, 1.65; d=-0.04), although levels of resiliency had increased with a medium-to-large effect (Mdiff=10.0; 95% CI=4.9, 15.1; d=0.78). For survivors of non-metastatic cancer, a synchronous, virtual mind-body resiliency program for FCR is feasible, acceptable, and seemingly beneficial compared to a community group referral.
Read full abstract