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Study Protocol
Evaluating a Web- and Telephone-based Personalised Exercise Intervention for Individuals Living With Metastatic Prostate Cancer (Exerciseguide): Protocol for a Pilot Randomised Controlled Trial
Camille E Short
Melbourne School of Psychological Sciences and Melbourne School of Health Sciences, University of Melbourne
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4177-4251
License:
This work is licensed under a CC BY 4.0 License. Read Full License
The most recent version of this article is available here.
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, 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) among individuals with metastatic prostate cancer.
Methods:
Sixty-six participants with histologically diagnosed metastatic prostate cancer will be randomised into either the eight-week intervention or a wait-list control. The intervention arm will have access to a tailored website, remote supervision, and three 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, 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 feasibilityof 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 10th December 2018, https://anzctr.org.au/ACTRN12618001979246.aspx
Keywords
Exercise, metastatic prostate cancer, behavioural change, eHealth, computer-tailoring, aerobic, resistance training
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CURRENT STATUS: Under Review
No community comments so far
Reviewer #2 agreed
On 13 Oct, 2020
Review #2 received
Received 13 Oct, 2020
Review #1 received
Received 12 Oct, 2020
Reviewer #1 agreed
On 11 Oct, 2020
Reviewers invited
Invitations sent on 09 Oct, 2020
Editor assigned
On 07 Oct, 2020
Submission checks complete
On 06 Oct, 2020
Editor invited
On 06 Oct, 2020
Version 1
Posted 02 Jul, 2020
No comments provided
Editorial decision: Minor revision
On 13 Sep, 2020
Review #2 received
Received 11 Sep, 2020
Reviewer #2 agreed
On 16 Aug, 2020
Review #1 received
Received 20 Jul, 2020
Reviewers invited
Invitations sent on 15 Jul, 2020
Reviewer #1 agreed
On 15 Jul, 2020
First submitted
On 29 Jun, 2020
Editor assigned
On 29 Jun, 2020
Submission checks complete
On 28 Jun, 2020
Editor invited
On 28 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Oncology
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This preprint is under consideration at Pilot and Feasibility Studies. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study Protocol
Evaluating a Web- and Telephone-based Personalised Exercise Intervention for Individuals Living With Metastatic Prostate Cancer (Exerciseguide): Protocol for a Pilot Randomised Controlled Trial
Camille E Short
Melbourne School of Psychological Sciences and Melbourne School of Health Sciences, University of Melbourne
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4177-4251
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
No community comments so far
Reviewer #2 agreed
On 13 Oct, 2020
Review #2 received
Received 13 Oct, 2020
Review #1 received
Received 12 Oct, 2020
Reviewer #1 agreed
On 11 Oct, 2020
Reviewers invited
Invitations sent on 09 Oct, 2020
Editor assigned
On 07 Oct, 2020
Submission checks complete
On 06 Oct, 2020
Editor invited
On 06 Oct, 2020
Version 1
Posted 02 Jul, 2020
No comments provided
Editorial decision: Minor revision
On 13 Sep, 2020
Review #2 received
Received 11 Sep, 2020
Reviewer #2 agreed
On 16 Aug, 2020
Review #1 received
Received 20 Jul, 2020
Reviewers invited
Invitations sent on 15 Jul, 2020
Reviewer #1 agreed
On 15 Jul, 2020
First submitted
On 29 Jun, 2020
Editor assigned
On 29 Jun, 2020
Submission checks complete
On 28 Jun, 2020
Editor invited
On 28 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Oncology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
The most recent version of this article is available here.
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, 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) among individuals with metastatic prostate cancer.
Methods:
Sixty-six participants with histologically diagnosed metastatic prostate cancer will be randomised into either the eight-week intervention or a wait-list control. The intervention arm will have access to a tailored website, remote supervision, and three 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, 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 feasibilityof 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 10th December 2018, https://anzctr.org.au/ACTRN12618001979246.aspx
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5