Prehabilitation and RecOVERy from surgery for Breast cancer (PROVERB)
Research type
Research Study
Full title
The feasibility of a multi-phasic exercise-based intervention utilising the Health Action Process Approach and wearable technology in women before and after surgery for breast cancer
IRAS ID
269464
Contact name
Amtul R Carmichael
Contact email
Sponsor organisation
Royal Derby Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Poor preoperative fitness and physical capacity are risk factors for postoperative complications, delayed recovery, and prolonged disability. Despite limited evidence in women with breast cancer, exercise-based prehabilitation in people with lung cancer, colon, and prostate cancer has shown beneficial effects on physical capacity, function, lung function, urinary continence, postoperative morbidity, quality of life and mood. Early intervention may also improve patient engagement and adherence in patients postoperative rehabilitation and exercise/physical activity. Exercise in this postoperative/pre-chemotherapy phase may prevent deconditioning and treatment-related morbidity and improve drug tolerance during adjuvant chemotherapy. However, there is a dearth of research during these phases (preoperative and postoperative/pre-chemotherapy) in patients with breast cancer.
A considerable challenge to the feasibility of all prehabilitation trials in cancer populations is the small “window of opportunity” between diagnosis and first treatment. Given these pre- and postoperative time constraints, participant’s adherence and fidelity to the exercise prescribed will be paramount. To facilitate adherence and fidelity the trial will adopt three strategies: 1) implementation of a remotely supervised exercise intervention; 2) utilization of behaviour change theory to support exercise-based prehabilitation adherence; and 3) the addition of wearable technology to facilitate exercise adherence and promote self-monitoring.
We aim to assess the feasibility of a pre- and post-operative/pre-chemotherapy, remotely supervised exercise-based intervention, employing wearable technology and behaviour change (Health Action Process Approach and dyadic coping strategies) counselling, in women diagnosed with breast cancer. We will also gather data pre-surgery, post-surgery, and pre-chemotherapy on objectively measured moderate-to-vigorous habitual physical activity, HAPA-related outcomes, dyadic related outcomes, patient-reported outcomes, surgical outcomes, and functional capacity measures. If the current study is found to be feasible then these data will be used to inform a future large randomised controlled trial.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
22/EM/0029
Date of REC Opinion
25 Mar 2022
REC opinion
Further Information Favourable Opinion