Process evaluation for the STAMINA randomised controlled trial: A protocol.

Abstract

STAMINA is a randomised controlled trial of a complex lifestyle intervention incorporating exercise prescription into a prostate cancer care pathway. The 12-month intervention aims to improve disease specific quality of life and reduce fatigue of people receiving androgen deprivation therapy for prostate cancer. Previously published work outlines the development of the trial intervention which included recruitment and training of healthcare professionals and exercise professionals to embed a lifestyle intervention and referral pathway within NHS prostate cancer care. A mixed-methods process evaluation, embedded within the STAMINA trial, will be conducted to assess quantitative process outcomes (recruitment, intervention reach, dose and fidelity), together with up to 45 qualitative interviews with patients, healthcare professionals and exercise professionals. Interviews will explore the perceptions and experiences of those involved in the STAMINA trial, and the organisational implications of embedding and sustaining the intervention. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before trial outcomes are known using an inductive and deductive approach. Findings from the different elements will be reported separately and then integrated to inform interpretation of trial outcomes. This process evaluation protocol provides a detailed description of relevant data collection methods and trial processes of the STAMINA randomised controlled trial which will allow us to determine whether the intervention can be delivered with fidelity, is acceptable to patients, healthcare professionals and exercise professionals, and understand the implications for embedding and sustaining the intervention in the routine care. ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.