Abstract
PURPOSE: After a cancer diagnosis, uncertainty is common. IN FOCUS is a pilot randomized controlled trial that evaluated the feasibility and acceptability of a virtual mind-body group resiliency intervention on fear of cancer recurrence (FCR). The current study examines secondary outcomes of this trial, specifically exploring changes in related mental health constructs, which will contribute to our understanding of symptom relief as well as diagnostic overlap and discrepancies.
METHODS: A single-blinded, 2-arm, randomized controlled trial was conducted from July 2021 to March 2022 comparing IN FOCUS (8 weekly, 90-min, synchronous virtual group classes teaching cognitive behavioral techniques, relaxation training, meditation, adaptive health behaviors, and positive psychology skills) to usual care (synchronous virtual community group support referral) among cancer survivors with non-metastatic disease and clinically elevated FCR (FCR Inventory severity ≥ 16). Secondary outcomes assessed included anxiety (PHQ-4), depression (PHQ-4), worry (Penn State Worry Questionnaire), health anxiety (Short Health Anxiety Inventory), intolerance of uncertainty (Intolerance of Uncertainty Scale), and cancer-related uncertainty (Mishel Uncertainty in Illness Scale-Survivor version). Intent-to-treat analyses with separate general linear mixed models were used to identify group-by-time effects (Cohen's d; 0.5 a medium effect, 0.8 a large effect) from baseline through 2 months and 5 months.
RESULTS: Sixty-four survivors enrolled (25-73 years old, M = 7 years since diagnosis, 83% female). By 5 months, IN FOCUS produced large effect size reductions in anxiety (d = - 0.83), medium effect size reductions in depression (d = - 0.45), health anxiety (d = - 0.54), and prospective intolerance of uncertainty (d = - 0.54), and small effect size reductions in inhibitory intolerance of uncertainty (d = - 0.39) and worry (d = - 0.38). Notably, cancer-related uncertainty did not change in either study arm (d = - 0.14).
CONCLUSIONS: Although in the parent trial IN FOCUS did not have a sustained effect on FCR, secondary analyses showed that IN FOCUS produced improvements in anxiety, depression, worry, and health anxiety 3 months post-treatment.
GOV ID: NCT04876599, Mind-body Resiliency Intervention for Fear of Cancer Recurrence.
TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04876599 IMPLICATIONS FOR CANCER SURVIVORS: While cancer survivors' uncertainties remained steady over time, their capacity to tolerate uncertainty seemed to improve after engaging in a novel virtual mind-body intervention.