Fatigue is rated as the most distressing side effect of
radiotherapy treatment for curable
breast cancer. About four in ten women treated experience
fatigue, which can last for years
after treatment. The impact of this debilitating tiredness is loss of independence and impaired physical and mental function. Our study will take a behavioural intervention with demonstrated effect in treating
fatigue in a mixed group of
chemotherapy patients and adapt it for women undergoing
radiotherapy for early
breast cancer. The purpose of this trial is to evaluate the feasibility of delivering the intervention in the
radiotherapy pathway for patients at a high risk of
fatigue and to explore participants' experiences of the trial and intervention.
METHODS: A pragmatic single-site non-blinded feasibility trial of a behavioural intervention. Main inclusion criteria are prescription of the UK standard 40 Gy in 15 fractions over 3 weeks of
radiotherapy (± tumour bed boost) for early (stage 0-IIIa)
breast cancer. The total projected sample size after attrition is 70. A previously developed
fatigue risk score tool will be used to predict individual's likelihood of experiencing
fatigue. Thirty women predicted to be at a high risk of experiencing significant
fatigue will be allocated in the ratio 2:1 to the behavioural intervention or education trial arms, respectively. These feasibility trial participants will be assessed at baseline, after 10 and 15 fractions of
radiotherapy and 10 days, 3 weeks and 6 months after
radiotherapy. A further 40 women predicted to be at a lower risk of
fatigue will join a risk score validation group.Measures to assess feasibility include recruitment, retention and completion rates and variation in implementation of the intervention. Process evaluation with intervention providers and users includes fidelity and adherence checks and qualitative interviews to understand how changes in behaviour are initiated and sustained.
DISCUSSION: This feasibility study collates data to both inform the progression to and design of a future definitive trial and to refine the intervention.
TRIAL REGISTRATION: ISRCTN 10303368. Registered August 2017 (retrospectively registered); Health and Care Research Wales Clinical Research Portfolio (CRP) registration 31419.