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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
10/12/2018
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivering a tailored evidence-based exercise intervention to support men with metastatic prostate cancer: A pilot randomized control trial examining behaviour change and functional quality of life
Scientific title
Delivering a tailored evidence-based exercise intervention to support men with metastatic prostate cancer: A pilot randomized control trial examining behaviour change and functional quality of life
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
78 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 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 8-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 designed by a behavioural scientist and accredited exercise physiologist. This approach (known as computer-tailoring) leads to the delivery of more personally relevant information, which increases message safety and efficacy. The modules include things like 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. To keep participants engaged and ensure participant's needs are met, new content and features (e.g., ask an expert module) will be unlocked on the website over time. This will be informed in part by participant feedback, which participants will be able to provide after each module by rating it out of 5 stars and leaving a comment if there are suggested improvements or topics not covered. To encourage module completion, a reminder will be sent to participants once a fortnight.
Intervention code [1] 312326 0
Behaviour
Comparator / control treatment
Control group
The control group will not be given access to the computer-tailored modules but will be given access to a basic physical activity promotion content (via the same website) that contains information that is already freely available. Previous research within the group has reviewed and ranked the content of existing websites and content will be developed inline with the top 10 websites that were identified. To control for the number of email contacts across the study groups, the control group will receive a fortnightly email prompting them to return to the website, and/or reminding them of website content. Provision of all content through the same website will ensure important website features (e.g., usability and aesthetics) are held constant across groups and allow for sophisticated tracking of online behaviour in both groups. This condition can be considered an optimized usual care control. Participants allocated to this group will be given access to the tailored modules at the end of the trial.

The freely available physical activity promotion content includes:
www.prostatecanceruk.org, www.urology.ucla.edu, www.pcf.org and www.andrologyaustralia.org.


Control group
Active

Outcomes
Primary outcome [1] 307332 0
Physical activity behaviour
I. Weekly minutes of light, moderate and vigorous physical activity will be measured using the ActiGraph(ActiGraph GT3X, http://www.theActiGraph.com) accelerometer. Worn on the waist or wrist during waking hours, the tool is a reliable and valid measure of energy expenditure. The ActiGraph is a research grade accelerometer and has been shown to be both valid and reliable measure of energy expenditure (Plasqui & Westerterp, 2007; Sasaki, John, & Freedson, 2011).

II. The adapted Godin leisure-time questionnaire will be used to assess self-reported aerobic and resistance based physical activity completed over the last month. This was used in a supervised based study within the same population (Cormieet al.,2013). Combined, these measures will provide us with the best possible data to explore intervention effects on physical activity behaviour (Broderick, Ryan, O'Donnell, & Hussey, 2014).
Timepoint [1] 307332 0
Week 0 (at baseline) and Week 9 post-baseline
Primary outcome [2] 307333 0
Quality of Life
Health-related quality of life will be assessed using the SF-36 (Ware, 1993). The items are scored to form eight subscales (general health, physical functioning, physical role, pain, vitality, social functioning, emotional role and mental health), which provide the basis for calculating two summary scores, a physical health summary score and a mental health summary score. It is a general quality of life measure used to determine the health benefits of different treatment options. The use of this measure will allow us the determine the impact of mental and physical functioning and examine the dose repose relationship to physical activity and quality of life. This tool was shown to be both valid and reliable in a study by Ware & Gandek in 1998.
Timepoint [2] 307333 0
Week 0 (at baseline) and Week 9 post-baseline
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, adverse events, 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] 354711 0
Overall satisfaction:
Overall satisfaction with the website as a health service will be assessed with the CSQ-8
Timepoint [6] 354711 0
Week 9 (post-baseline)
Secondary outcome [7] 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 [7] 354712 0
Week 9 (post-baseline)
Secondary outcome [8] 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 [8] 354713 0
Week 9 (post-baseline)
Secondary outcome [9] 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 [9] 354714 0
Week 1 (post baseline). The intervention will start week 2 and post-testing will occur week 10 (post-baseline)

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
Currently have contraindications to performing moderate physical activity (resistance, aerobic and flexibility) for at least 20 minutes, up to three days of the week.
Already be meeting the upper-limit of the resistance-training guidelines for cancer survivors (3 sessions per week).

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
Not yet 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 examine the effect of tailored exercise content on physical activity and quality of life in men with prostate cancer.

Who is it for?
You may be eligible for this study if you are living with metastatic prostate cancer and have access to a computer.

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. The other group (comparator) will receive published physical activity information through the same website and will be offered the tailored program at the end of the study.

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
Freemasons Foundation Centre for Men’s Health
Faculty of Health Sciences, The University of Adelaide
Level 7, South Australian Health & Medical Research Institute, North Terrace, Adelaide, SA, 5005
Country 86810 0
Australia
Phone 86810 0
+61 8 8313 0532
Fax 86810 0
Email 86810 0
camille.short@adelaide.edu.au
Contact person for public queries
Name 86811 0
Dr Camille Short
Address 86811 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health Sciences, The University of Adelaide
Level 7, South Australian Health & Medical Research Institute, North Terrace, Adelaide, SA, 5005
Country 86811 0
Australia
Phone 86811 0
+61 8 8313 0532
Fax 86811 0
Email 86811 0
camille.short@adelaide.edu.au
Contact person for scientific queries
Name 86812 0
Dr Camille Short
Address 86812 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health Sciences, The University of Adelaide
Level 7, South Australian Health & Medical Research Institute, North Terrace, Adelaide, SA, 5005
Country 86812 0
Australia
Phone 86812 0
+61 8 8313 0532
Fax 86812 0
Email 86812 0
camille.short@adelaide.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.
By what mechanism will data be made available?
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
Not applicable