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
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.
Summary of Results
This study investigated whether a remotely supervised exercise programme could support women undergoing breast cancer surgery. The intervention combined structured physical activity with psychological support strategies, specifically the Health Action Process Approach and dyadic coping, and was supported by wearable technology to monitor progress.
Thirty-four women took part in our study, with an average age of 60 years, and average body mass index of 30.0 kg/m². Most of the women were postmenopausal (79%) and identified as White British (91%). The most common cancer type was invasive ductal carcinoma (59%), and around half of participants were diagnosed with stage III disease
The primary aim of the study was to assess feasibility, including recruitment, retention, adherence, and safety. The recruitment target of 34 participants was achieved, although recruitment was slower than planned and required a three-month extension. Retention was high, with 85% of participants completing the post-intervention assessment and 76% retained at three months, exceeding prespecified targets (>75%).
Participants completed both supervised and unsupervised exercise sessions before and after surgery. Before surgery, participants attended an average of 86% of supervised sessions, with over three-quarters meeting the predefined adherence threshold (>70% of planned sessions). After surgery, adherence to supervised sessions remained high, with an average attendance of 100% and more than 85% of participants meeting attendance targets (>70% of planned sessions). Technical issues with wearable devices limited the availability of data for unsupervised sessions. Among those with usable data, adherence to unsupervised exercise was good: 83% (9/11) met the 60% threshold before surgery and 88% (7/8) after surgery.
The exercise programme was safe and well tolerated. Around 6 in 10 women reported no adverse events. A total of 61 adverse events were recorded, the majority of which were mild and related to musculoskeletal discomfort or common symptoms associated with breast cancer treatment. Only two serious adverse events occurred, both unrelated to the exercise programme, and none occurred during exercise sessions.
Physical function showed encouraging improvements over time. Walking ability, assessed using the six-minute walk test, increased by 56.4 metres from baseline to post-intervention and by 46.8 metres from baseline to three-month follow-up. Both improvements exceed the 30-metre threshold commonly considered clinically meaningful. Estimated cardiovascular fitness showed a similar pattern, with maximal oxygen uptake (VO₂max) by 2.9 ml·kg⁻¹·min⁻¹ from baseline to post-intervention. Participants also showed small gains in lower-body strength, with 30 second sit-to-stand performance increasing on average by 3.5 repetitions over the course of the study. Grip strength declined slightly after surgery (−1.2 kg in the surgical arm and −0.6 kg in the non-surgical arm relative to baseline) but recovered following the intervention, although changes remained below clinically meaningful thresholds (3.5kg). Shoulder range of motion in the surgical arm partially recovered from post-operative losses, improving on average 62 degrees in the surgical arm between surgery and end of study follow up, though data completeness was affected by the mid-trial loss of a key technology provider. Lymphedema index values remained stable over time, with no clinically meaningful changes detected.
Patient-reported outcomes showed expected short-term declines after surgery, followed by recovery in several areas. Dyadic coping scores, reflecting how couples manage stress together increased by around 5.1 points shortly after surgery, before returning toward baseline by three months with scores 4.0 points lower than at post-intervention. Quality of life domains declined after surgery but partially or fully recovered post-intervention: on average physical function improved by 12.1 points, role function by 23.1 points, and social function by 19.3 points between post-operative and post-intervention assessment. While fatigue increased by 6.8 points over the same period, although pain decreased by 25 points but remained 5.3 points above baseline. Emotional wellbeing remained largely stable, while cognitive function increased on average by 16.7 points post intervention relative to baseline. Sexual function showed small fluctuations over time. Sexual enjoyment decreased by 33.3 points between post-intervention and three-month follow-up. Body image scores decreased by 20.8 points following surgery, improved following the intervention but remained 11.1 points lower than at baseline. Body image also declined between post intervention assessment and three month follow up by on average 16.7 points, indicating partial but incomplete recovery. Disability scores increased on average by 17 points after surgery, and although improvements were observed scores remained 9.2 points above baseline following the intervention. Shoulder pain and dysfunction also improved after the intervention, with reductions of 12.3 points relative to post-operative scores. Musculoskeletal health initially declined on average after surgery by 9.4 points, but subsequently improved on average by 5.9 points between post operative and post-intervention assessment, and was maintained at three months.
Despite these encouraging findings, our study had some limitations. This was a feasibility trial with a small sample size and no control group, meaning it was not designed to test effectiveness, but to assess feasibility and inform future larger studies to evaluate the intervention’s benefits. Technical issues with wearable devices affected data quality and completeness for unsupervised exercise adherence and shoulder range of motion.
In conclusion, this study demonstrates that a remotely supervised, multi-phase exercise programme is feasible, safe, and acceptable for women undergoing breast cancer surgery. Feasibility was demonstrated through the successful completion of recruitment, despite slower-than-expected initial uptake, the target sample size was ultimately achieved, and by the high rates of attendance and adherence both before and after surgery. Safety was supported by the low number of adverse events, the majority of which were mild, and the two serious events that occurred were unrelated to the intervention. Acceptability was reflected by participants’ strong adherence with the programme, as well as the positive feedback given during trial focus groups.
In addition to demonstrating promise of the intervention, participants also showed encouraging trends in physical function, quality of life, and partner support, indicating that the intervention may offer potential benefits for recovery and wellbeing. Together, these findings support the potential for larger, multicentre trials to evaluate the clinical and cost effectiveness of this intervention.
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