Pilot Randomized Controlled Trial of IN FOCUS: A Mind‐Body Resiliency Intervention for Fear of Cancer Recurrence

Abstract

IntroductionFear 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.ObjectiveThis pilot randomized controlled trial (NCT04876599) tested a synchronous, virtual mind‐body group resiliency intervention for FCR (IN FOCUS).MethodAdults 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 ≥ 3 days 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 2 months (primary endpoint) and 5 months using intention‐to‐treat.ResultsFrom July 2021 to March 2022, 64 survivors enrolled (25–73 years old, M = 7 years 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 2 months, 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 5 months, 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).ConclusionsFor 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.