Abstract
IntroductionPreliminary research has shown the effectiveness of supervised exercise-based interventions in alleviating sequela resulting from metastatic prostate cancer. Despite this, many individuals do not engage in sufficient exercise to gain the benefits. There are many barriers, which limit the uptake of face-to-face exercise in this population including lack of suitable facilities, remoteness, and access to experts, significant fatigue, urinary incontinence and motivation. Technology-enabled interventions offer a distance-based alternative. This protocol describes a pilot two-armed randomised controlled study that will investigate the feasibility and preliminary efficacy of an online exercise and behavioural change tool (ExerciseGuide) amongst individuals with metastatic prostate cancer.MethodsSixty-six participants with histologically diagnosed metastatic prostate cancer will be randomised into either the 8-week intervention or a wait-list control. The intervention arm will have access to a tailored website, remote supervision, and tele-coaching sessions to enhance support and adherence. Algorithms will individually prescribe resistance and aerobic exercise based upon factors such as metastasis location, pain, fatigue, confidence and current exercise levels. Behavioural change strategies and education on exercise benefits, safety and lifestyle are also tailored through the website. The primary outcome will be intervention feasibility (safety, usability, acceptability, and adherence). Secondary exploratory outcomes include changes in physical activity, quality of life, sleep, and physical function. Outcomes will be measured at baseline and week 9.DiscussionThe study aims to determine the potential feasibility of an online remotely monitored exercise intervention developed for individuals with metastatic prostate cancer. If feasible, this pilot intervention will inform the design and implementation of further distance-based interventions.Trial registrationANZCTR, ACTRN12614001268639. Registered 10 December 2018, https://anzctr.org.au/ACTRN12618001979246.aspx
Highlights
Preliminary research has shown the effectiveness of supervised exercise-based interventions in alleviating sequela resulting from metastatic prostate cancer
Algorithms will individually prescribe resistance and aerobic exercise based upon factors such as metastasis location, pain, fatigue, confidence and current exercise levels
The study aims to determine the potential feasibility of an online remotely monitored exercise intervention developed for individuals with metastatic prostate cancer
Summary
Study design This study is a two-arm pilot randomised control trial with participants randomised into either the intervention group (8 weeks) or a wait-list control group. Module ratings Website perceived personal relevance [52] Client Satisfaction Questionnaire [34] Perceived Environmental Supportiveness Scale [53] Qualitative data (open-ended survey questions and qualitative interview) Software usability scale [35] Website usage data [54] Number of exercise sessions Common Terminology Criteria for Adverse Events V.5.0 grading criteria Self-efficacy [55] Outcome expectations [55] Motivation type [56] Social Support [55] Intention [57] Behavioural capability [52] Habit formation [43] ActiGraph Accelerometer [54] Modified Godin-Leisure time questionnaire [12] Self-rated exercise adherence [58] European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 [59] Functional Assessment of Chronic Illness Therapy-fatigue subscale [60] Hospital Anxiety and Depression Scale [61] The Pittsburgh Sleep Quality Index [62] 400 m self-paced walk [14] Timed up-and-go test [12] Repeated chair stand [63] One-repetition maximum [14]. Approved amendments will be subsequently distributed to participants through the study website
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