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Trial registered on ANZCTR


Registration number
ACTRN12618001979246
Ethics application status
Approved
Date submitted
4/09/2018
Date registered
10/12/2018
Date last updated
19/05/2020
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivering an individualised web-based exercise intervention to support individuals with metastatic prostate cancer: A pilot randomised control trial
Scientific title
Delivering an individualised web-based exercise intervention to support individuals with metastatic prostate cancer: A pilot randomised control trial
Secondary ID [1] 295997 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 309518 0
Condition category
Condition code
Cancer 308348 308348 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312326 0
Behaviour
Comparator / control treatment
Control group (wait-list)
Participants in the control group will be placed on a waitlist and will be asked to continue with usual care for eight weeks. Once they have been re-tested in week 9, the control group will be given access to the intervention website. It will not be possible to deliver the full-intervention to participants (with on-going access to an EP) at the end of the trial due to resource restrictions, however, control group participants will be given access to the computer-tailored modules, 1 phone conversation with an EP and a Theraband to support their participation in resistance-training after the trial.

Control group
Active

Outcomes
Primary outcome [1] 307332 0
The success of the intervention will be interpreted based on the following pre-established criteria as is the recent protocol in pilot studies, The pre-established criteria include: (1) The software usability is satisfactory (score of 68 on the SUS usability scale; (2) the acceptability of the intervention is satisfactory (score of 20 on the client satisfaction questionnaire; (3) there are no grade 3+/life threatening or severe adverse events attributed to participating in the intervention; (4) there is evidence of meaningful participation in either aerobic activity or resistance-based activity in the intervention group relative to the control. As the exercise prescription will be personalised it is difficult to specify an average cut-point, however we would anticipate a between-group difference of at least 30 minutes of aerobic activity or 1 or more sessions of resistance activity across a week using the modified godin-leisure time questionnaire.
Timepoint [1] 307332 0
Week 0 (at baseline), weeks 1-8 (intervention) and week 9 (post-intervention).
Secondary outcome [1] 351493 0
Intervention Acceptability
In both conditions, participant's perceptions of website content will be assessed in real time using a five-star rating system (1-Poor to 5-Excellent).


Timepoint [1] 351493 0
Week 9 post-baseline
Secondary outcome [2] 351494 0
Intervention Feasibility: Key trial parameters of screening rates, eligibility, consent, randomisation, retention, completion and missing data will be also assessed.
Timepoint [2] 351494 0
Week 9 post-baseline
Secondary outcome [3] 354675 0
Physical function:
I. 400m self-paced walk will assess physical function and is as an important measure of mobility disability, submaximal aerobic capacity and ability to live independently. The test has been shown to be both reliable and valid in older populations (Rolland et al. 2004).
II. The timed up-and-go testis a functional test of muscular power and ambulation and was used in testing this population previously (Cormie 2013)
III. Repeated chair stand (5 repetitions) is a clinical test which is commonly used to assessed the functional muscle strength of the lower limbs of the older adult and has been found to be valid and reliable (Bohannon 2012).
Timepoint [3] 354675 0
Week 1 (post baseline). The intervention will start week 2 and post-testing will occur week 10 (post-baseline)
Secondary outcome [4] 354676 0
Lower Limb Muscular strength: The 1-RM method will be utilized to determine muscular strength as used by Galvao et al. 2018.
The leg extension will be used to determine lower limb strength,
It is important to note that patients with proximal femur bone lesions will be excluded from the leg extension 1-RM
Timepoint [4] 354676 0
Week 1 (post baseline). The intervention will start week 2 and post-testing will occur week 10 (post-baseline)
Secondary outcome [5] 354710 0
Website usage:
Website usage data including the number of logins, time on site and number of modules completed will be assessed using Google analytics and inbuilt website tracking software. The data will give information on feasibility and acceptability (Short, Rebar, Plotnikoff, & Vandelanotte, 2015).
Timepoint [5] 354710 0
Week 9 (post-baseline)
Secondary outcome [6] 354712 0
Relevance
The perceived personal relevance of website content will be assessed using three items designed to evaluate the success of tailoring on a 7 point Likert scale.
Timepoint [6] 354712 0
Week 9 (post-baseline)
Secondary outcome [7] 354713 0
Website engagement
Website engagement will be assessed using the 12-item eHealth engagement scale (Lefebvre, Tada, Hilfiker, & Baur, 2010) and system usability scale (Brooke, 1996), which collectively assess that extent that the website was absorbing, credible, convincing and usable. This information will be supplemented with data collected from open-ended survey questions exploring pros and cons of the website and recommendations for improvement
Timepoint [7] 354713 0
Week 9 (post-baseline)
Secondary outcome [8] 354714 0
Upper Limb Muscular strength: The 1-RM method will be utilized to determine muscular strength as used by Galvao et al. 2018.
The chest press will assess upper limb strength. It is important to note that patients with rib/thoracic spine lesions and humerus lesions will be excluded from the chest press 1-RM.
Timepoint [8] 354714 0
Week 1 (post baseline). The intervention will start week 2 and post-testing will occur week 10 (post-baseline)
Secondary outcome [9] 379937 0
Physical activity levels
Accelerometry will be used to objectively measure weekly minutes of light, moderate and vigorous physical activity. Data will be collected using the ActiGraph accelerometer, which will be worn on the waist during waking hours for a period of 7. days.

The adapted Godin leisure-time questionnaire will also be used to assess self-reported aerobic and resistance based physical activity completed over the last month.
Timepoint [9] 379937 0
Week 0 and week 9
Secondary outcome [10] 379938 0
Quality of life
Health-related quality of life will be assessed using the EORTC Quality of Life-Core 30 (QLQ-C30). The 30-item core survey assesses a comprehensive range of quality of life domains including functioning (physical, role, cognitive, emotional and social), symptoms (fatigue, nausea and vomiting, sleep, pain, appetite, shortness of breath), financial hardship, and global health status.
Timepoint [10] 379938 0
Week 0 and week 9
Secondary outcome [11] 379939 0
Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue subscale will be administered to measure participants level of fatigue.
Timepoint [11] 379939 0
Week 0 and week 9
Secondary outcome [12] 379940 0
Hospital Anxiety and Depression Scale (HADS) will be used to evaluate changes in anxiety and depression
Timepoint [12] 379940 0
Week 0 and 9
Secondary outcome [13] 379941 0
The Pittsburgh Sleep Quality Index questionnaire will be used to measure sleep quality pre and post-intervention
Timepoint [13] 379941 0
Week 0 and Week 9
Secondary outcome [14] 379942 0
Self-efficacy
Self-efficacy will be assessed using 9-items based on a previous 8-item scale, which was developed and tested by Plotnikoff et al..2001. An extra item was added based off of previous research by Short et al. (2012). Participants will be asked to rate their confidence (ie: (1) not at all confident to (5) very confident) that they can participate in regular aerobic exercise over the next eight weeks. This is replicated for resistance training.
Timepoint [14] 379942 0
Week 0 and week 9
Secondary outcome [15] 379943 0
Outcome expectations
Outcome expectations are measured using 5 general items from the validated exercise pros subscale (Plotnikoff et al. 2001) with 3-additional items developed for this study based on formative research among cancer survivors. The items in the scale assess the extent that individuals agree or disagree (1) strongly disagree to (5) strongly agree) that participating in regular PA over the next 8 weeks would for them: An example item includes “Over the next four months, participating in regular exercise will help make me feel more confident about my health.”
Timepoint [15] 379943 0
Week 0 and week 9
Secondary outcome [16] 379944 0
Knowledge of exercise
Knowledge will be assessed using a newly developed 3-item questionnaire based off of formative research to provide an understanding of participants knowledge of exercise for individuals with prostate cancer.
Timepoint [16] 379944 0
Week 0 and week 9
Secondary outcome [17] 379945 0
Behaviour intentions
Behaviour intentions will be assessed using 2 items for aerobic exercise and 2 items for resistance exercise using specifically developed items developed from work based off of Rhodes and Rebar (2017).
Timepoint [17] 379945 0
Week 0 and week 9
Secondary outcome [18] 379946 0
Habit measure
Habit automaticity will be assessed using the automaticity subscale (4 items) from the Self-report Habit Index as described by Gardener et al (2012).
Timepoint [18] 379946 0
Week 0 and week 9
Secondary outcome [19] 379947 0
Motivation
Behavioural Regulation in Exercise Questionnaire (BREQ) will be used to assess motivation type using 19-items. The items in the scale assess the extent that individuals agree or disagree ((0) Not true for me to (5) very true for me) statements regarding how they personally feel about exercise.
Timepoint [19] 379947 0
Week 0 and week 9
Secondary outcome [20] 379948 0
Social support
Social support is assessed using a specifically developed 2-item social support for exercise habits scale. Participants will be asked to rate how much they agree or disagree (1)?strongly disagree to (5) strongly agree) with the following statements: People in your social network are likely to help you participate in regular exercise (go for a walk together, give advice); Someone in your social network will provide the support you need in order to be regularly active (be accountable or encouraging).
Timepoint [20] 379948 0
Week 0 and week 9

Eligibility
Key inclusion criteria
To be eligible, participants must be living with metastatic prostate cancer. They need to have access to a computer with the internet and be able to read and write in English. Lastly, they need to have consent from their physician with a note from their physician detailing the extent and location of metastases.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be ineligible if they have any contraindications to performing moderate physical activity (resistance, aerobic and flexibility) for at least 20 minutes, up to two days of the week. This includes no recent serious cardiovascular events (within 12?months, including but not limited to, unstable bone metastases, spinal compressions, transient ischaemic attack, cerebrovascular accident or myocardial infarction), acute pulmonary embolus or infarction, acute myocarditis or pericarditis, aneurysm or an acute infection. Participants will also be excluded from the study if they are already participating in two sessions of resistance-training and 60 minutes of structured moderate-vigorous aerobic exercise per week (participants meeting one target but not the other will be eligible).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Quantitative Analysis
All analyses will be conducted according to the intention to treat principle as outlined by White et al2011. Namely, the main analysis will be conducted using all observed data (ie: a completers analysis) and sensitivity analysis (accounting for all randomised participants) will be conducted to explore the impact of missing data. Multiple imputation and pattern-mixture modelling will be used to investigate the robustness of conclusions to different missing data mechanisms. Any discrepancies will be reported and their implications discussed. All analyses will be completed in R (version 3.4). Descriptive statistics will be calculated for all study variables. ANCOVAs (or non-parametric equivalents) will be used to conduct between-group comparisons, with confounders identified in the literature as covariates (eg. Age, physical capability, baseline physical activity and quality of life). Treatment effects will be estimated as covariate-adjusted mean differences between the two treatment groups at follow up. A senior University of Adelaide statistician employed by the Freemasons Foundation Centre for Men's Health will oversee the analyses.

Qualitative Analysis
Any verbal feedback from participants will be recorded (with permission) and transcribed verbatim. Verbal and written feedback(from open-ended questions)will be analysed using General Inductive Analysis, which has been advocated for the use in health research (Thomas 2006). This approach is data-driven and involves becoming familiar with the data, generating initial codes, searching for themes among codes and refining the themes to better fit the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300593 0
Charities/Societies/Foundations
Name [1] 300593 0
ANZUP
Address [1] 300593 0
Chris O'Brien Lifehouse,
Level 6, 119-143 Missenden Road,
Camperdown NSW 2050
Country [1] 300593 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Ground Floor
254 North Terrace
The University of Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 300092 0
None
Name [1] 300092 0
Address [1] 300092 0
Country [1] 300092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301378 0
The Adelaide University Human Research Ethics Committee
Ethics committee address [1] 301378 0
RESEARCH SERVICES OFFICE OF RESEARCH ETHICS, COMPLIANCE AND INTEGRITY
THE UNIVERSITY OF ADELAIDE
LEVEL 4, RUNDLE MALL PLAZA
50 RUNDLE MALL
ADELAIDE SA 5000 AUSTRALIA
Ethics committee country [1] 301378 0
Australia
Date submitted for ethics approval [1] 301378 0
Approval date [1] 301378 0
25/07/2018
Ethics approval number [1] 301378 0
H-2018-153

Summary
Brief summary
The purpose of this study is to determine whether an 8-week website-based exercise plus phone support is safe, acceptable and feasible for men. It will also investigate effects on quality of life, physical function and physical activity.

Who is it for?
We are looking for men who have metastatic prostate cancer who are not already participating in multi-modal exercise on a regular basis (multimodal exercise is a mixture of cardio and strength training). Clearance from your physician (general practitioner, medical oncologist, radiation oncologist or urologist), as well as internet access, is required.

Study details
Participants will be randomly (by chance) assigned into two groups. One group (intervention) will have free access to a web-based physical activity support tool for 8 weeks. The website provides recommended exercises, goal setting/tracking and habit-building tips, which are delivered based on individual characteristics such as metastases location, pain levels and previous exercise experience. Those in this group will also receive phone support throughout the 8 weeks. The other group (comparator) will be placed on a wait-list for 8 weeks and post week 9 testing will be given access to a similar website.
All participants will be asked to complete quality of life, exercise and intervention acceptability questionnaires, Participants will also be required to track activity via an accelerometer. A subset of participants will be asked to complete supervised physical function and muscular strength testing if applicable.

It is hoped this research will demonstrate the usefulness of offering tailored exercise advice through a web-based portal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86810 0
Dr Camille Short
Address 86810 0
Melbourne School of Psychological Sciences and Melbourne School of Health Sciences
Faculty of Medicine, Dentistry, and Health Sciences
Room 812, Redmond Barry Building, Parkville
The University of Melbourne, Victoria 3010 Australia
Country 86810 0
Australia
Phone 86810 0
+61 03 8344 1192
Fax 86810 0
Email 86810 0
camille.short@unimelb.edu.au
Contact person for public queries
Name 86811 0
Dr Camille Short
Address 86811 0
Melbourne School of Psychological Sciences and Melbourne School of Health Sciences
Faculty of Medicine, Dentistry, and Health Sciences
Room 812, Redmond Barry Building, Parkville
The University of Melbourne, Victoria 3010 Australia
Country 86811 0
Australia
Phone 86811 0
+61 03 8344 1192
Fax 86811 0
Email 86811 0
camille.short@unimelb.edu.au
Contact person for scientific queries
Name 86812 0
Dr Camille Short
Address 86812 0
Melbourne School of Psychological Sciences and Melbourne School of Health Sciences
Faculty of Medicine, Dentistry, and Health Sciences
Room 812, Redmond Barry Building, Parkville
The University of Melbourne, Victoria 3010 Australia
Country 86812 0
Australia
Phone 86812 0
+61 03 8344 1192
Fax 86812 0
Email 86812 0
camille.short@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The demographics, usability data, movement screening and knowledge levels (plus the data dictionary) will be stored on Figshare in line with Freemasons Foundation Centre for Men's Health Policy. Identifiable data will never be made public. De-identifiable data may be shared to allow others to re-run analyses.
When will data be available (start and end dates)?
Data will be available once the analysis has been undertaken and completed. The aim will be to have this analysis completed by January 2020. No end date.
Available to whom?
Only researchers who provide a methodologically sound proposal will have access to the de-identified data. This will be made on a case-by-case basis at the discretion of Primary Sponsor and the Freemasons Foundation Centre for Men's Health (in which the primary sponsor is an employee of)
Available for what types of analyses?
The intention of making the data available will be to facilitate scientific transparency and integrity, or to extend the benefits of the data (e.g., combining our data with other data sets in an individual patient-data meta-analysis). de-identified will be made clear to participants on the information sheet.
How or where can data be obtained?
The data will be made available through Figshare. Access will be subject to approvals by Principal Investigator and will have a requirement to sign a data access agreement
What supporting documents are/will be available?
No other documents available
Summary results
No Results