Detailed description of multidisciplinary prehabilitation in patients admitted to nerve sparring radical prostatectomy – A randomized feasibility study protocol

• Published in: Contemporary clinical trials communications Vol. 40; p. 101319
• Main Authors: Blumenau Pedersen, Malene, Saxton, John M., Rasmussen Villumsen, Brigitta, Bjerggaard Jensen, Jørgen, Birch, Sara
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01-08-2024; Elsevier
• Subjects: Complex interventions; Prehabilitation; Preventive medicine; Prostate cancer; Surgery; Preventive medicine; Prehabilitation; Prostate cancer; Surgery; Complex interventions
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2024.101319

Localized prostate cancer treated with radical prostatectomy is highly effective, though severe side-effects are common after the surgery. Prehabilitation is an approach to optimize patient's physical and mental resources before surgery, to improve postoperative outcomes. The feasibility of a multi-modal home-based prehabilitation program, delivered using telehealth in patients awaiting radical prostatectomy is unknown. This paper describes the development of a prehabilitation program for patients awaiting radical prostatectomy.
A model by The Medical Research Council for developing and evaluating complex interventions (MRC Framework) was used in the development process. The Template for Intervention Description and Replication (TIDieR) checklist was applied for ensuring sufficient description of the interventions. A total of 40 patients will be randomized to either intervention or control group. Patients in the control group will follow standard care. The 4-week prehabilitation programme consists of exercise, pelvic floor exercise, sexual counseling, stress management and nutritional support. The interventions are home-based and delivered using telehealth. Feasibility outcomes will include recruitment, attrition rates, adherence, safety and suitability.
We have developed a multimodal prehabilitation programme, which has the potential to bring tangible health benefits to men with prostate cancer awaiting radical prostatectomy. The results of the feasibility study will inform the design of a fully powered randomized controlled trial.
•Side effects are common for patients receiving a radical prostatectomy.•Prehabilitation consist of pre-surgical interventions to optimize surgical outcomes.•Using a biopsychosocial approach, we have developed a prehabilitation program.•The TIDieR checklist was used for transparently describing the development.•A randomized clinical study is designed to examine if prehabilitation is feasible.