Holly E L Evans1, Cynthia C Forbes2, Daniel A Galvão3, Corneel Vandelanotte4, Robert U Newton3,5, Gary Wittert1, Suzanne Chambers6, Andrew D Vincent1, Ganessan Kichenadasse7, Nicholas Brook8, Danielle Girard9, Camille E Short10,11. 1. Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia. 2. Wolfson Palliative Care Research Centre, Institute of Clinical and Applied Health Research, University of Hull, Hull, United Kingdom. 3. Exercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, Australia. 4. School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, Central Queensland University, North Rockhampton, Queensland, Australia. 5. School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia. 6. Faculty of Health, University of Technology, Sydney, New South Wales, Australia. 7. College of Medicine and Public Health, Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia. 8. Department of Surgery, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia. 9. Alliance for Research in Exercise, Nutrition and Activity, Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia. 10. Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia. Camille.short@unimelb.edu.au. 11. Melbourne Centre for Behaviour Change, Faculty of Medicine, Dentistry, and Health Sciences, The University of Melbourne, Parkville, Victoria, Australia. Camille.short@unimelb.edu.au.
Abstract
INTRODUCTION: Preliminary 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. METHODS:Sixty-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. DISCUSSION: The 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 REGISTRATION: ANZCTR, ACTRN12614001268639 . Registered 10 December 2018, https://anzctr.org.au/ACTRN12618001979246.aspx.
RCT Entities:
INTRODUCTION: Preliminary 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. METHODS: Sixty-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. DISCUSSION: The 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 REGISTRATION: ANZCTR, ACTRN12614001268639 . Registered 10 December 2018, https://anzctr.org.au/ACTRN12618001979246.aspx.
Authors: Nicolas H Hart; Robert U Newton; Nigel A Spry; Dennis R Taaffe; Suzanne K Chambers; Kynan T Feeney; David J Joseph; Andrew D Redfern; Tom Ferguson; Daniel A Galvão Journal: BMJ Open Date: 2017-05-30 Impact factor: 2.692
Authors: An-Wen Chan; Jennifer M Tetzlaff; Douglas G Altman; Andreas Laupacis; Peter C Gøtzsche; Karmela Krleža-Jerić; Asbjørn Hróbjartsson; Howard Mann; Kay Dickersin; Jesse A Berlin; Caroline J Doré; Wendy R Parulekar; William S M Summerskill; Trish Groves; Kenneth F Schulz; Harold C Sox; Frank W Rockhold; Drummond Rennie; David Moher Journal: Ann Intern Med Date: 2013-02-05 Impact factor: 25.391
Authors: Stacey A Kenfield; Nicolas H Hart; Robert U Newton; June M Chan; Kerry S Courneya; James Catto; Stephen P Finn; Rosemary Greenwood; Daniel C Hughes; Lorelei Mucci; Stephen R Plymate; Stephan F E Praet; Emer M Guinan; Erin L Van Blarigan; Orla Casey; Mark Buzza; Sam Gledhill; Li Zhang; Daniel A Galvão; Charles J Ryan; Fred Saad Journal: BMJ Open Date: 2018-05-14 Impact factor: 2.692
Authors: Holly E L Evans; Daniel A Galvão; Cynthia C Forbes; Danielle Girard; Corneel Vandelanotte; Robert U Newton; Andrew D Vincent; Gary Wittert; Ganessan Kichenadasse; Suzanne Chambers; Nicholas Brook; Camille E Short Journal: Cancers (Basel) Date: 2021-11-25 Impact factor: 6.639
Authors: Jordan Curry; Michael Lind; Camille E Short; Corneel Vandelanotte; Holly E L Evans; Mark Pearson; Cynthia C Forbes Journal: Pilot Feasibility Stud Date: 2022-08-13