Recruitment and follow-up complete.

NIHR Programme Grant for Applied Research (preceded by a NIHR Programme development grant) and Nuffield Health.

STAMINA was a five-year research project funded by the National Institute for Health Research (NIHR) in the UK.

It was designed around a pre-existing NICE research recommendation to assess the long-term impact of supervised exercise training on both quality of life and fatigue in men on androgen deprivation therapy (ADT).

Nuffield Health were key strategic partners during the programme design and delivery. 

The programme had 5 major work packages:

1. To describe current clinical pathways of care for men with prostate cancer being treated with androgen deprivation therapy (ADT) across the NHS (Pre-COVID).

2. To develop a complex behavioural intervention of supervised exercise training and diet advice for men with prostate cancer on ADT, that could be integrated into the NHS core cancer care pathways.

3. To conduct a pre-pilot of this intervention to assess acceptability and elements of feasibility.

4. A definitive multi-centre RCT of the STAMINA Lifestyle Intervention (SLI) vs behaviourally optimised usual care assessing clinical effectiveness.

5. A parallel cost effectiveness evaluation.

1. Can a behaviourally informed lifestyle intervention with extended support embedded in existing standard NHS prostate cancer care pathways (SLI) confer long-term benefits in cancer-specific quality of life and fatigue, compared with usual care?

2. Can the SLI be cost-effective when compared with usual care?

NIHR Programme grant with interdigitating work packages, culminating in a nationwide multi-centre RCT.

Primary analysis published September 2026 in the Lancet Oncology.

In the largest study of its kind to date, to our knowledge, the STAMINA lifestyle intervention provided superior mitigation effects on the Functional Assessment of Cancer Therapy–prostate (FACT-P), the Functional Assessment of Chronic Illness Therapy–fatigue, FACT–general (FACT-G), and the EuroQol five dimensions, five levels outcomes at 12 months, over a behaviourally Optimised Usual Care as well as consistently superior exercise behaviour.

STAMINA lifestyle intervention provided cancer-specific quality-of-life benefits, which exceeded the minimum clinically important difference threshold (ie, >3 points on FACT-G) and importantly provided positive long-term effects across subdomains. STAMINA lifestyle intervention is cost-effective compared with Optimised Usual Care, being deliverable for £13 920 per quality-adjusted life years and costing less than £1000 per annum even under the more expensive scenario examined.

A unique feature of STAMINA lifestyle intervention was the integration of the lifestyle prescription into the standard prostate cancer clinical pathway for men being prescribed ADT. Partnering with Nuffield Health, who delivered supervised exercise via their national infrastructure, ensured that if demonstrated to be positive, STAMINA lifestyle intervention could be implemented at scale immediately.

These data directly address lingering uncertainties around the quality of evidence and the absence of core delivery infrastructure underpinning the utility of these interventions.

Professor Liam Bourke:
l.bourke@shu.ac.uk

Professor Derek Rosario:
derek.rosario@nhs.net

• Bourke L, Rosario DJ, Reale S, Ibeggazene S, Innes A, Scope A, Price G, Taylor S, Steed L, Sutton E, Stokes J, Hewison J, Morrissey D, Doherty P, Brown J, Meads D, O’Dwyer JL, Deniszczyc D, Greenfield DM, Mason M, Collinson M, Farrin A. An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multi-centre randomised clinical trial. Lancet Oncology, 2026.

• Ibeggazene S, Turner R, Rosario D, Bourke L. Remote interventions to improve exercise behaviour in sedentary people living with and beyond cancer: a systematic review and meta-analysis. BMC Cancer. 2021 Mar 24;21(1):308.

• Bourke L, Turner R, Greasley R et al. A multi-centre investigation of delivering national guidelines on exercise training for men with advanced prostate cancer undergoing androgen deprivation therapy in the UK NHS.PLoS One. 2018; 13(7):e0197606.

• Reale S, Turner RR, Sutton E, et al. Towards implementing exercise into the prostate cancer care pathway: development of a theory and evidence-based intervention to train community-based exercise professionals to support change in patient exercise behaviour (The STAMINA trial).BMC Health Serv Res. 2021;21(1):264.

• McNaught E, Reale S, Bourke L et al. 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. Trials. 2024;25(1):257.

• Reale S, Turner RR, Sutton E et al. Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial).Sci Rep. 2021; 11(1):12470

• Turner RR, Arden MA, Reale S, Sutton E, Taylor SJC, Bourke L, Greenfield DM, Morrissey D, Brown J, Doherty P, Rosario DJ, Steed L. The development of a theory and evidence-based intervention to aid implementation of exercise into the prostate cancer care pathway with a focus on healthcare professional behaviour, the STAMINA trial. BMC Health Serv Res. 2021 Mar 25;21(1):273.

• Reale S, Turner RR, Steed L, Taylor SJC, Rosario DJ, Bourke L, Morrissey D, Innes AQ, Sutton E. Using Normalisation Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: the STAMINA lifestyle intervention.Implement Sci Commun. 2024 Sep 2;5(1):94.