None listed
Conditions
Brief summary
This study is testing a new multifactorial online platform called PRO-Health which provides individualised educational material on prostate cancer, its treatment side effects, and individualised nutrition and exercise services delivered to you anytime, anywhere in Australia. Who is it for? You may be eligible for this study if you are an adult with a confirmed diagnosis of prostate cancer and have been receiving androgen deprivation therapy (ADT) for at least 3 months. You should also not be currently meeting the dietary and exercise guidelines for cancer survivors or under the care of a nutrition or exercise health professional. Study details Participants will be randomly assigned to either receive usual care from their treating practitioner, or receive individualised consultations from a dietitian (4 sessions) and exercise physiologist (4 sessions) over a period of 12 weeks. These will involve dietary and exercise prescriptions that are tailored to participants based on their medical history, and reflect guidelines for prostate cancer patients. The usual care group will also receive access to PRO-Health and a consultation from a dietitian or exercise physiologist after the 12 week period. Participants will be asked to complete a body composition scan (equipment couriered), physical function test over Zoom that is facilitated by a research team member, and asked to completed questionnaires over a 12-week period from baseline. It is hoped that findings from this study will help develop this PRO-Health platform to help prostate cancer patients manage side effects from androgen deprivation therapy.
Interventions
This is a 12-week pilot randomised controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of PRO-Health: a multifactorial online platform that provides individualised educational material on (i) prostate cancer and treatment side effects and (ii) nutrition and exercise behaviour change multimedia to support remotely delivered nutrition and exercise video-consultation from a dietitian and exercise physiologist. The program will specifically target men with prostate cancer treated with androgen deprivation therapy. Participants will be randomised (1:1 ratio) to the usual care group or the PRO-Health intervention after baseline testing. Those receiving the PRO-Health intervention will receive the following combined nutrition and exercise intervention in parallel. Nutrition Participants will receive 4x individualised nutrition consultations with an accredited practising dietitian delivered via video-consultation using Zoom Video Communications ™. Consultations will be scheduled at Baseline, Week 2, 4 and 8. The initial consultation will be 60-minutes with review consultations being 45-mins. At each consultation the dietitian will follow a standardised medical nutrition therapy protocol where the initial assessment will: •Assess current clinical symptoms, treatment side effects, weight history, and social history. •Review dietary intake using a standardised 24-hr dietary recall. •Create a personalised dietary plan to meet dietary targets: (i) protein (1.2-1.5g/kg/day); (ii) calculate energy requirements with restrictions of 500-1000 kJ/day; (iii) general healthy eating for cardiovascular health. Recommendations are derived from the American Society of Clinical Oncology (ASCO) Exercise, Nutrition and Weight management during cancer treatment guidelines and the American Cancer Society (ASC) nutrition and physical activity guidelines for cancer survivors. •Following the Coventry, Aberdeen & London - Refined (CALO-RE) behaviour change taxonomy framework PRO-Health includes nutrition education material, a personalised dietary plan, and recipes to support dietary behaviour change. •Review consultations will follow the same structure but also evaluate adherence (24-hr recall, session attendance) to dietary goals and progressively change dietary intake where needed. Exercise The exercise component of this intervention will consist of 4x individualised exercise consultation with an exercise physiologist using Zoom Video Communications ™. Consultations will be scheduled at Baseline, Week 1 (optional check-in), 2, 4 and 8. The initial consultation will be 90-minutes with review consultations being 60-mins. Exercise equipment (resistance band and yoga mat) will be couriered to participants in advance. The consultation structure will follow: •Assess and evaluate any contraindications to exercise (including past medical history) and environment for safe exercise. •Explanation of exercise technique and form with demonstrations of exercise performed by the participants. •The exercise prescription will contain 3 sessions/week of combined (1) aerobic exercise (moderate intensity: 50-70% HRmax) lasting 30-mins walking/cycling (including a warm-up and cool-down) and (2) resistance-band training lasting 40-mins at a moderate intensity aiming for 2-3 sets of 8-12 repetitions of 6-8 exercises targeting major muscle groups (i.e., banded chest press, bent over row, squat, lunge). •Following the CALO-RE behaviour change taxonomy framework PRO-Health includes exercise education material and videos of the exercises with written description. To monitor adherence to the exercise program after each exercise session participants will be asked to rate their rating of perceived exertion, level of pain, enjoyment, and completion of the exercise session through PRO-Health. •Review consultations will follow the same structure but also modify the exercise prescript where needed. After 12-weeks participants in the intervention group will be asked to participate in a semi-structured interview. Guided by the Consolidated Framework for Implementation Research, the interviews will explore participants experiences of the study procedure, intervention components, education material, self-efficacy and future alterations required for PRO-Health. The first 12 participants that opt-in to the interview will be interviewed. Interviews will be conducted by PI Baguley.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age 18+ years 2. A diagnosis of prostate cancer and treated with Androgen Deprivation Therapy for >3 months 3. Body mass index <40 kg/m2 4. Not currently meeting the dietary and exercise guidelines for cancer survivors or under the care of a nutrition or exercise health professional 5. Not taking any supplements other than a single multivitamin; unless stated for medical purpose (i.e., vitamin D supplement for low bone mineral density) 6. Free of any musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study. 7. Access to a smart device with stable internet and video capabilities 8. English is your primary language
Exclusion criteria
1. Body mass index <24.9 kg/m2 (healthy weight or underweight), weight >200 kg 2. Bone metastases 3. Any electronic medical implant such as a pacemaker