Targeted self-management limits fatigue for women undergoing radiotherapy for early breast cancer: results from the ACTIVE randomised feasibility trial

PURPOSE: The ACTIVE intervention uses a novel fatigue propensity tool to target a behavioural fatigue self-management programme for women undergoing radiotherapy for early breast cancer. We assess feasibility and outcomes for ACTIVE. METHODS: Mixed methods comprised a randomised feasibility trial with qualitative process evaluation and a nested fatigue risk substudy. Participants at a higher risk of fatigue were allocated 2:1 to behavioural intervention or information alone. Participants at a lower risk of fatigue entered the fatigue risk substudy. Feasibility was assessed by rates of eligibility, recruitment, retention and adherence. Qualitative interviews explored acceptability of the intervention and trial processes. Measures of fatigue, anxiety, depression, quality of life and self-efficacy were self-reported before, during and 10 days, 3 weeks and 6 months after radiotherapy. Pre-treatment fatigue risk score and post-treatment fatigue were correlated. RESULTS: Fifty percent (n = 75) of eligible patients were recruited with 33 higher risk participants randomised to the trial and 42 entering the fatigue risk score substudy. Trial design and methods were feasible and acceptable with 91% of participants completing all measures according to protocol. Fatigue was clinically-significantly lower in the intervention group during, and in the weeks after, treatment compared to the control: all secondary measures favoured the intervention group. Positive group differences were not maintained at 6 months. CONCLUSION: Our targeted approach to fatigue self-management is feasible and acceptable within the early breast cancer pathway. Multiple benefits were reported by patients who received the intervention, which is worthy of further investigation. TRIAL REGISTRATION: ISRCTN 10303368. Registered August 2017. Health and Care Research Wales Clinical Trial Portfolio Registration 31419.