Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial)

Abstract

IntroductionObese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer.Methods and analysisA single-blinded, two-arm parallel group, non-inferiority randomised trial will be undertaken with 104 overweight/obese men with prostate cancer (body fat percentage ≥25%) randomly allocated in a ratio of 1:1 to a telehealth-delivered, virtually supervised exercise and nutrition programme or a clinic-based, face-to-face supervised exercise and nutrition programme. Exercise will consist of supervised resistance and aerobic exercise performed three times a week plus additional self-directed aerobic exercise performed 4 days/week for the first 6 months. Thereafter, for months 7–12, the programmes will be self-managed. The primary endpoint will be fat mass. Secondary endpoints include lean mass and abdominal aortic calcification, anthropometric measures and blood pressure assessment, objective measures of physical function and physical activity levels, patient-reported outcomes and blood markers. Measurements will be undertaken at baseline, 6 months (post intervention), and at 12 months of follow-up. Data will be analysed using intention-to-treat and per protocol approaches.Ethics and disseminationEthics approval has been obtained from the Edith Cowan University Human Research Ethics Committee (ID: 2021–02157-GALVAO). Outcomes from the study will be published in academic journals and presented in scientific and consumer meetings.Trial registration numberACTRN12621001312831.

Prostate Cancer Survivorship Essentials for men with prostate cancer on androgen deprivation therapy: protocol for a randomised controlled trial of a tele-based nurse-led survivorship care intervention (PCEssentials Hormone Therapy Study)

“…Godin-Shephard Leisure-Time Physical Activity Questionnaire, 51 modified to include questions on resistance training, reflecting current best practice in exercise intervention trials for men with PCa, 52 will assess physical activity.…”

PC-PEP, a Comprehensive Daily Six-Month Home-Based Patient Empowerment Program Leads to Weight Loss in Men with Prostate Cancer: A Secondary Analysis of a Clinical Trial

“…Additionally, weight loss may optimize the effectiveness of adjuvant treatments [ 6 ]. Behavioural weight management interventions have been proven to decrease weight and improve health outcomes in select cancer types, although comprehensive methodological assessments regarding their application in the context of prostate cancer are notably limited [ 9 , 10 ].…”

Feasibility of supervised telehealth exercise for patients with advanced melanoma receiving checkpoint inhibitor therapy

“…Patients with cancer, 9 especially those of increasing age and comorbidities, 10 are at an increased risk of mortality if infected with COVID‐19. Accordingly, the utilisation of telehealth, that is, the use of telecommunication techniques for the delivery of health services and transmission of health information over a distance, 11 has been suggested as an alternative method of exercise delivery for patients with cancer 12,13 . Previous studies examining telehealth exercise programmes in patients with different types of cancer (primarily breast and prostate cancer) report symptom relief and no adverse events 14,15 .…”

“…Accordingly, the utilisation of telehealth, that is, the use of telecommunication techniques for the delivery of health services and transmission of health information over a distance, 11 has been suggested as an alternative method of exercise delivery for patients with cancer. 12 , 13 Previous studies examining telehealth exercise programmes in patients with different types of cancer (primarily breast and prostate cancer) report symptom relief and no adverse events. 14 , 15 Therefore, this study aimed to determine the feasibility, safety and explore the preliminary efficacy of a telehealth supervised exercise programme in patients with melanoma receiving checkpoint inhibitor therapy.…”