Process evaluation for the STAMINA randomised controlled trial: A protocol

Area of Science:

• Oncology
• Lifestyle Medicine
• Clinical Trials

Background:

• The STAMINA trial investigates a 12-month complex lifestyle intervention for prostate cancer patients undergoing androgen deprivation therapy.
• The intervention integrates exercise prescription into standard prostate cancer care pathways.
• Previous work detailed the intervention's development, including healthcare and exercise professional training for integration into NHS care.

Purpose of the Study:

• To conduct a mixed-methods process evaluation of the STAMINA trial.
• To assess quantitative process outcomes like recruitment, reach, dose, and fidelity.
• To explore patient and professional experiences and organizational implications for intervention sustainability.

Main Methods:

• Mixed-methods approach combining quantitative process data and qualitative interviews.
• Quantitative data on recruitment, reach, dose, and fidelity analyzed descriptively.
• Qualitative data from up to 45 interviews with patients and professionals analyzed using inductive and deductive methods.

Main Results:

• The process evaluation protocol details data collection methods for the STAMINA trial.
• It aims to determine intervention fidelity and acceptability among participants and professionals.
• Findings will inform the interpretation of trial outcomes regarding embedding and sustaining the intervention.

Conclusions:

• This protocol outlines the methods for evaluating the STAMINA trial's implementation.
• It will assess the feasibility and acceptability of integrating lifestyle interventions into routine prostate cancer care.
• The evaluation will provide insights into sustaining such interventions in clinical practice.