Reducing fatigue in women undergoing radiotherapy for breast cancer
Research type
Research Study
Full title
ACTIVE: A randomised feasibility trial of a behavioural intervention to reduce fatigue in women undergoing radiotherapy for early breast cancer
IRAS ID
200075
Contact name
Nicholas Courtier
Contact email
Clinicaltrials.gov Identifier
16/WA/0205, Wales REC 3
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
ACTIVE: A randomised feasibility trial of a behavioural intervention to reduce fatigue in women undergoing radiotherapy for early breast cancer
Fatigue is rated as the most distressing side effect of radiotherapy treatment for early stage breast cancer. About four-in-ten women treated experience cancer-related fatigue (CRF), which can last for years after treatment. The Welsh Standards for Rehabilitation of Cancer Patients highlight the need for interventions to help people cope with the side effects of treatments.
Interventions that motivate helpful thoughts and behaviour change have been successful at reducing CRF. What remains unclear is the best way to deliver self-managed interventions, the necessary ingredients and an understanding of why they only work for some patients.
Our study takes a behaviourally-orientated intervention – which has shown promise in treating fatigue in a varied group of chemotherapy patients – and adapts it for women undergoing radiotherapy for breast cancer who are at a high risk of fatigue.
The primary aim of our project is to evaluate trial processes to determine if the trial is feasible and acceptable to deliver in the radiotherapy pathway. The secondary aim is to evaluate participant’s experiences and opinions of the intervention, as a basis for refinement for a future definitive trial.
Patients will be recruited at a single cancer centre over a period of nine months.Patients will be screened to predict their likelihood of experiencing fatigue using a previously developed tool. Thirty women predicted to be at a high risk of experiencing significant fatigue will be randomly allocated (in the ratio 2:1) to receive the 'behavioural intervention' or 'education alone' (about CRF), respectively.
A Tenovus Cancer Care Innovation Grant has funded this study.REC name
Wales REC 3
REC reference
16/WA/0205
Date of REC Opinion
30 Aug 2016
REC opinion
Further Information Favourable Opinion