Feasibility Randomised Controlled Trial of a New Digital Intervention ('FRAME') to Promote Resilience in Women Treated for Primary Breast Cancer.

Abstract

Objective: This study investigates the acceptability of a novel Cognitive Bias Modification for Interpretation (CBM-I) intervention, 'FRAME', to promote resilience in women who have completed active treatment for primary breast cancer and determines the feasibility of a full-scale randomised controlled trial.

Methods: A two-armed, participant-blind, parallel groups randomised controlled trial of CBM-I versus a time-matched control. Participants were recruited from community organisations and social media. Measures of acceptability, feasibility, change in interpretation bias and clinical outcomes (resilience, mood and quality of life) were assessed at baseline (T0), 1-month post-randomisation (T1, end of intervention), 2-month (T2) and 4-month post-randomisation (T3).

Results: Sixty-seven participants completed baseline assessment and were randomised to the FRAME CBM-I (n = 35) or control group (n = 32). Acceptability of CBM-I met pre-specified progression criteria, and 80% adhered to the CBM-I intervention. Between-group differences in interpretation bias at T1 demonstrated a moderate effect in favour of CBM-I on two measures of interpretation bias (SMD_g = 0.66 and 0.73). Effect size estimates suggest moderate treatment effects on resilience (SMD_g = 0.64) and small effects on mood, in favour of FRAME. No intervention-related adverse events were reported.

Conclusions: The study results provide strong support for the acceptability of a new online CBM-I intervention ('FRAME') to promote resilience in women treated for primary breast cancer and indicate that a full-scale trial is feasible. The study fulfiled all pre-specified progression criteria to advance to an efficacy trial, except meeting the recruitment target of 70 participants. Importantly, recruitment took place during the Covid-19 pandemic. Recommendations for future research are provided.