Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation.

BACKGROUND: UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention offers a system-level change to clinical care delivery addressing barriers to long-term behaviour change and implementation of new prostate cancer care pathways. This trial aims to establish whether STAMINA is clinically and cost-effective in improving cancer-specific quality of life and/or reducing fatigue compared to optimised usual care. The process evaluation aims to inform the interpretation of results and, if the intervention is shown to benefit patients, to inform the implementation of the intervention into the NHS. METHODS: Men with prostate cancer on androgen deprivation therapy (n = 697) will be identified from a minimum of 12 UK NHS trusts to participate in a multi-centre, two-arm, individually randomised controlled trial. Consenting men will have a 'safety to exercise' check and be randomly allocated (5:4) to the STAMINA lifestyle intervention (n = 384) or optimised usual care (n = 313). Outcomes will be collected at baseline, 3-, 6- and 12-month post-randomisation. The two primary outcomes are cancer-specific quality of life and fatigue. The parallel process evaluation will follow a mixed-methods approach to explore recruitment and aspects of the intervention including, reach, fidelity, acceptability, and implementation. An economic evaluation will estimate the cost-effectiveness of the STAMINA lifestyle intervention versus optimised usual care and a discrete choice experiment will explore patient preferences. DISCUSSION: The STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services. TRIAL REGISTRATION: ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

Patient-rated satisfaction and improvement following hip and knee replacements: Development of prediction models.

RATIONALE: Effective preoperative assessments of determinants of health status and function may improve postoperative outcomes. AIMS AND OBJECTIVES: We developed risk scores of preoperative patient factors and patient-reported outcome measures (PROMs) as predictors of patient-rated satisfaction and improvement following hip and knee replacements. PATIENTS AND METHODS: Prospectively collected National Health Service and independent sector patient data (n = 30,457), including patients' self-reported demographics, comorbidities, PROMs (Oxford Hip/Knee score (OHS/OKS) and European Quality of Life (EQ5D index and health-scale), were analysed. Outcomes were defined as patient-reported satisfaction and improvement following surgery at 7-month follow-up. Univariable and multivariable-adjusted logistic regressions were undertaken to build prediction models; model discrimination was evaluated with the concordance index (c-index) and nomograms were developed to allow the estimation of probabilities. RESULTS: Of the 14,651 subjects with responses for satisfaction following hip replacements 564 (3.8%) reported dissatisfaction, and 1433 (9.2%) of the 15,560 following knee replacement reported dissatisfaction. A total of 14,662 had responses for perceived improvement following hip replacement (lack of improvement in 391; 2.7%) and 15,588 following knee replacement (lack of improvements in 1092; 7.0%). Patients reporting poor outcomes had worse preoperative PROMs. Several factors, including age, gender, patient comorbidities and EQ5D, were included in the final prediction models: C-indices of these models were 0.613 and 0.618 for dissatisfaction and lack of improvement, respectively, for hip replacement and 0.614 and 0.598, respectively, for knee replacement. CONCLUSIONS: Using easily accessible preoperative patient factors, including PROMs, we developed models which may help predict dissatisfaction and lack of improvement following hip and knee replacements and facilitate risk stratification and decision-making processes.