Delivering an individualised web-based exercise intervention to support individuals with metastatic prostate cancer: A pilot randomised control trial

Participant recruitment and consent 66 participants will be recruited for this study and need to have consent from their physician with a note from their physician detailing the extent and location of metastases. Participants will be recruited using convenience-sampling methods. Design and procedure If deemed (potentially) eligible, participants will register for the study via the web-based platform and provide contact details. Participants will be asked to wear the Actigraph activity monitor for seven consecutive days during waking hours (except when bathing or swimming). A baseline questionnaire will assess demographic information, thoughts and feelings about physical activity, self-reported physical activity over the last month and quality of life. In addition to the above measures, a subset of participants (n ~ 30) will be invited to complete a face-to-face testing of functional capacity. In these sessions, functional outcome measures such as dynamic strength, agility and aerobic capacity will be assessed. A qualified exercise professional (Exercise Physiologist, Physiotherapist or Exercise Scientist) will be available onsite and will observe the assessment session. Subgroup selection will be based on proximity to available testing sites, with all participants who are able to easily access one of our testing sites invited to complete subgroup measures. The purpose of the subgroup assessments is to examine the feasibility of assessing functional capacity objectively and to obtain preliminary insight into the efficacy of the intervention for improving important functional outcomes. All baseline assessments (except for demographic questions) will be reassessed at the 9-week post-baseline (immediate post-intervention) follow-up. As well as collecting quantitative outcome data, participants will also be invited to provide qualitative feedback about the intervention, and any existing unmet needs at the end of the trial, and/or upon withdrawal from the trial. Randomisation Once baseline data has been collected, participants will be randomised into the intervention group or the control group at a ratio of 1:1. This will be completed using a computer-generated random number sequence in block sizes of 4. Randomisation will be stratified based on age and physical capability. The developed software will automatically complete the randomization. Participants will not be blinded to the primary goal of the project (evaluation of web-based tool in this population) but will not be informed of the specific hypothesis. Intervention group: Web-based physical activity support tool The intervention group will have free access to a web-based computer-tailored exercise tool for a period of 8 weeks. The content, delivered via modules, will be adjusted based on individual characteristics through an automated computer process. This approach (known as computer tailoring) leads to the delivery of more personally relevant information, which increases message safety and efficacy (Lustria et al., 2013; Vandelanotte et al., 2016; Wolfenden et al., 2014). The modules include things like an 8-week exercise program with video demonstrations of recommended exercises, interactive activities to assist with goal setting and tracking progress over-time, and tips and strategies for building habits and social support for exercise plans. Participants will be free to complete the modules as many times as they like over the course of the intervention. Participants will be mailed resources to help them to complete the exercises recommended for them (e.g., resistance-training bands). To keep participants engaged in the program participants will also have access to an accredited exercise physiologist (HE). The role of the exercise physiologist will be to encourage uptake of the 8-week individually prescribed program, provide feedback and monitor progress over the 8 week intervention period. Recent reviews of online digital behaviour change interventions suggest that human support is the most effective intervention component for effectiveness in online interventions (Santarossa et al, 2018). The exercise physiologist will make contact with participants allocated to the intervention during week one of the program (by phone or internet call). They will discuss participant goals, provide advice about how best to use the program to achieve their goals, and offer remote monitoring of participant progress throughout the 8 weeks. Remote monitoring will involve reviewing data entered into the website by participants on a weekly basis and providing encouragement, feedback and advice based on performance. Contact after week one will occur via email and text messages (up to one per week), with the exception of week three which will involve a follow-up call (by phone or internet). Participants will have the option of submitting questions to the exercise physiologist whenever they would like to via the ask the EP (exercise physiologist) feature of the website. Responses will be sent to participants electronically where possible.