None listed
Conditions
Brief summary
The purpose of this research study is to implement and evaluate a sexual function and cardiovascular health-targeted intervention during and following treatment for prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and you have been, or have previously been, diagnosed with prostate cancer. Study details Participants in this study will be randomly allocated (by chance) to either 12-weeks of an exercise intervention or usual care. Participants in the exercise intervention group complete cardiorespiratory/aerobic, resistance and stretching exercises on 3 days of the week; which are individually tailored to each intervention participant. Participants in both groups are required to undertake assessments both before and after the 12-week intervention period. These assessments are related to sexual function, cardiovascular disease risk development and other health measures (e.g. body composition, blood markers, cardiorespiratory fitness). Some participants will also be invited to attend a focus group discussion on the quality and feasibility of the intervention after intervention completion.
Interventions
This study involves two components. The first, an interventional study which will compare the effects of a 12-week exercise intervention to usual care in men who have, or who have previously had, prostate cancer. The second, a situational appraisal of this exercise intervention. 1. Exercise Intervention The intervention will be a structured and individualised 12-week exercise program with the following components: 1) Participants will aim to complete 36 one-hour exercise sessions during this 12-week period (equating to three exercise sessions per week) in either a supervised gymnasium or in the participant’s community/home (if deemed the participant is able to safely and effectively complete their exercises unsupervised). If participants are unable to reach the target 36 sessions during these 12 weeks (i.e. they miss sessions due to excess treatment-related side effects), then they will be provided with the option of performing make-up sessions during this 12-week period (i.e. a participant may complete two sessions one week, then four sessions the following week). Alternatively, participants will be provided with the option of completing as many of the remaining sessions as possible during one additional week, making the intervention 13 weeks in duration (at most) for these participants. 2) Supervised exercise sessions will either be individual or group-based and be supervised by an accredited exercise physiologist (AEP). Unsupervised home-based exercise sessions will be individual. 3) The exercise intervention will taper from fully supervised (weeks 1-4) to partially supervised with self-managed sessions (weeks 5-12). 4) Each session will include a tailored exercise program, including a combination of high intensity aerobic and resistance exercises. These tailored exercise programs will be reviewed after each exercise session and will take into account each participant’s disease-status, exercise performance and exercise preferences. High-intensity exercise will be individualised to the participants’ cardiorespiratory fitness and closely monitored by the AEP. 5) Exercise programs will be delivered via a computer/phone application (Physitrack®) and thus can be accessed by participants both during their supervised and self-managed home-based sessions. Participants will be provided with coaching on how to use the phone application during their initial supervised exercise sessions. If participants are unwilling and/or unable to use the phone application, then a paper version of their exercise program will be provided, with the AEP then manually entering the participants completed exercises into Physitrack®. 2. Situational Appraisal Princess Alexandra Hospital clinicians (medical oncologists, prostate cancer nurses, physiotherapists, and service managers) and intervention participants will be invited to attend focus groups. Participants will be required to attend one of two focus groups, lasting no longer than 90 minutes in duration. Participants will be asked questions regarding resource utilisation, the knowledge and skills needed to implement the intervention, as well as cultural and structure barriers and facilitators.
Sponsors
Study design
Eligibility
Inclusion criteria
- Men with a histologically-confirmed diagnosis of prostate cancer - Sexual dysfunction score of moderate (score = 8-11/25), mild-to-moderate (score = 12-16/25), or mild (score = 17-21/25), as assessed by the abridged version of the International Index of Erectile Function (IIEF-5) - Undergoing watchful waiting, active surveillance, or previous or concurrent treatment with any anti-cancer treatment/s - Aged >18 years - >4 weeks since major surgery - No co-morbid condition or falls risk that could prevent safe completion of the intervention - Cognitively capable of consent
Exclusion criteria
- Planning to undergo surgery during the intervention period - Any intellectual or physical disability which would make exercise intervention participation unsafe for the individual