Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001978257
Ethics application status
Approved
Date submitted
4/09/2018
Date registered
10/12/2018
Date last updated
5/02/2020
Date data sharing statement initially provided
10/12/2018
Date results provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and usability testing of a web-based physical activity guidance tool for men with metastatic prostate cancer
Scientific title
Development and usability testing of a web-based physical activity guidance tool for men with metastatic prostate cancer
Secondary ID [1] 295995 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 309508 0
Condition category
Condition code
Cancer 308341 308341 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1–
The intervention will be developed in collaboration with the exercise medicine research group at Edith Cowan University, who specialize in exercise prescription for men with prostate cancer. The group have already developed an effective face-to-face program for men with bone metastases (Galvão et al., 2011), which we will adapt for use in an online setting. To ensure the end product is person-centred, we will conduct qualitative research as part of the intervention design process (n = ~10). This is considered best practice for designing digital health interventions that meet user needs (Yardley et al, 2016). Once we have a working prototype, we will then conduct usability and safety tests within a controlled setting. A small sample of men with metastatic prostate cancer(n = ~10)will be invited to utilize the intervention in a lab-based setting. This will involve navigating around the website, generating and viewing their tailored exercise prescription and then undertaking the recommended exercises (without and then with the use of a mirror).
Stage 1. Baseline data collection (15 minutes)
Participants are asked to complete a questionnaire assessing demographics, health-related
information, current exercise levels, exercise goals, and self-rated exercise knowledge and
confidence
and outcome expectations.
Stage 2. Usability testing - think-aloud test. (30 minutes)
Participants are asked to perform key tasks on the website and prompted to think aloud while doing so. The tasks include completing the exercise prescription module to generate their tailored exercise recommendation.
Stage 3. Free-time to privately use the website (5-10 minutes)
Stage 4. Direct observation. (30-45minutes)
Participants complete a face-to-face assessment to determine their suitability for performing the exercises recommended by the website. Participants are asked to perform all safe exercises whilst being recorded with and without a mirror. The use of the mirror (or not) will be randomized to reduce the impact of practice effects. For each exercise, the participant will watch the video as many times as necessary, complete their own set-up and when they believe they are ready to complete the exercise, they will let the researcher know. They will complete 6-8 repetitions per exercise. Exercises prescribed will be based on metastases location, pain levels, previous experience, fatigue levels and confidence in exercise. Exercise include but are not limited to seated exercise band press, standing exercise row, seated march, supine single leg extension (in hook lie), quarter squat, exercise band knee extension and standing calf raise. To ensure participant safety while performing the exercises, a qualified exercise professional will be available onsite and will observe the session. They will be instructed to ensure the participant does not complete any exercises that would put them at risk and to offer assistance if the individual requires it. If any assistance or corrections are provided, this will be documented and reported as part of the evaluation of the website.
Stage 5. Follow-up assessment. (20 minutes)
Participants are asked to complete a brief questionnaire re-assessing baseline questions about exercise knowledge, confidence and outcome expectations, as well as the system usability scale and acceptability items relating to relevance, usefulness and credibility. Participants are also asked to participate in a brief interview regarding what they liked and did not like about the website.

In total, the duration of the intervention will be 2 hours, however, the participant is welcome to cease testing at any time.

This process will be filmed with the participants permission. An Independent review board of experienced exercise physiologists will review the footage to objectively assess the quality of the prescription provided by the website and the participant’s exercise technique using an evidence-based pro forma. The panel will be asked to rate the quality of the technique, in
terms of safety and efficacy on a scale of 0 (unsatisfactory) to 3(good) using an evidence-based proforma. The average rating for each exercise reviewed, as well as inter-rater reliability of reviewers will be reported.

Where possible, identified issues will be addressed before the next participant utilizes the website. Testing will continue until no major issues are identified. This method of evaluation will ensure participant safety, whilst also allowing us to test proof of concept and iron out any system errors or safety concerns before progressing to phase 2.
Intervention code [1] 312322 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307328 0
Website Usability Testing:
Usability will be assessed using mixed methods. This will include a think-aloud test, where users are prompted to think aloud while performing key tasks on the website. This is useful for identifying usability flaws more salient to end users, and also for identifying the underlying causes of usability issues. Usability will also be assessed quantitatively via the system usability scale (Brooke, 1996).
Timepoint [1] 307328 0
Week 1 of intervention
Secondary outcome [1] 351490 0
Movement Screening Analysis:
In the intervention, participants will be asked to complete exercises deemed safe by the exercise physiologist, with and without a technique aid (mirror). These will be recorded from two camera angles. The footage will be reviewed by an independent panel of exercise physiologists (n = 3 to 5) with at least five years of experience. The panel will be asked to rate the quality of the technique, in terms of safety and efficacy on a scale of 0 (unsatisfactory) to 3(good) using an evidence-based proforma. The average rating for each exercise reviewed, For example, if unsatisfactory ratings are consistently reported for a particular exercise, we will consider removing the exercise, or revising how it is demonstrated. The results will also be used to guide recommendations for website use. For example, if we recommend future users to utilise a mirror when using it at home in order to improve their technique.
Timepoint [1] 351490 0
Week 2 (post-intervention)
Secondary outcome [2] 351491 0
Acceptability.
Website acceptability will assess perceived relevance, usefulness and credibility. It is assessed through a purpose-built survey and be assessed using mixed methods. This will be a composite secondary outcome.
Timepoint [2] 351491 0
Week 1 of intervention
Secondary outcome [3] 354715 0
Acceptability - Qualitative
Qualitative interview probing user's like and do not like about the website and advice provided, as well as any recommendations for approval.
Timepoint [3] 354715 0
Week 1 of intervention
Secondary outcome [4] 354716 0
inter-rater reliability of reviewers will be reported
Timepoint [4] 354716 0
Week 2 (post-intervention)

Eligibility
Key inclusion criteria
-Be living with metastatic prostate cancer
-Be able to attend a single face-to-face session at the South Australian Health and Medical research Institute (Adelaide) or the Edith Cowan Exercise Medicine Lab (Perth).
-Feel they are well enough to participate in some form of aerobic, strength or flexibility exercise for 5 minutes or more (if they wanted to).
-Have consent from their physician
-Provide a note from their physician detailing the extent and location of metastases
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to read and write in English
- Have a current spinal cord compression or unstable fracture

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be calculated for all study variables.

Usability issues will be tabulated by the investigator and shared with the computer programmer and design team as soon as possible. To determine agreement between review board members, the Inter-rater reliability with be determined using Kappa coefficient and absolute agreement.

Changes in participants’ knowledgeand confidence between pre and post-exposure will be calculated using paired sample t-tests. This will be done using Stata version 11.

General Inductive Analysis(as outlined above) will be used to analyse participants responses regarding what they liked and did not like about the intervention.

Descriptive statistics ofsatisfactory ratings will be used to identify any safety issues and areas for improvement.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2018
Actual
1/01/2019
Date of last participant enrolment
Anticipated
17/01/2019
Actual
26/07/2019
Date of last data collection
Anticipated
31/01/2019
Actual
7/08/2019
Sample size
Target
10
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
SA,VIC

Funding & Sponsors
Funding source category [1] 300590 0
Charities/Societies/Foundations
Name [1] 300590 0
ANZUP Below the Belt
Country [1] 300590 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Ground Floor
254 North Terrace
The University of Adelaide
SA 5005 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 300084 0
None
Name [1] 300084 0
Address [1] 300084 0
Country [1] 300084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301377 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 301377 0
Ethics committee country [1] 301377 0
Australia
Date submitted for ethics approval [1] 301377 0
Approval date [1] 301377 0
02/05/2018
Ethics approval number [1] 301377 0
H-2017-174

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86806 0
Dr Camille Short
Address 86806 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health and Medical Sciences, Adelaide University
Level 7, South Australian Health & Medical Research Institute, North Terrace, Adelaide, SA, 5005
Country 86806 0
Australia
Phone 86806 0
+61 8 831 30532
Fax 86806 0
Email 86806 0
camille.short@adelaide.edu.au
Contact person for public queries
Name 86807 0
Camille Short
Address 86807 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health and Medical Sciences, Adelaide University
Level 7, South Australian Health & Medical Research Institute, North Terrace, Adelaide, SA, 5005
Country 86807 0
Australia
Phone 86807 0
+61 8 8313 0532
Fax 86807 0
Email 86807 0
camille.short@adelaide.edu.au
Contact person for scientific queries
Name 86808 0
Camille Short
Address 86808 0
Freemasons Foundation Centre for Men’s Health
Faculty of Health and Medical Sciences, Adelaide University
Level 7, South Australian Health & Medical Research Institute, North Terrace, Adelaide, SA, 5005
Country 86808 0
Australia
Phone 86808 0
+61 8 831 30532
Fax 86808 0
Email 86808 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 February 2019. No end date.
Available to whom?
Only researchers who provide a methodologically sound proposal will have access to the deidentified 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). This 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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 375937-(Uploaded-08-02-2022-15-02-10)-Basic results summary.docx
Plain language summaryNo Following a patient-centred iterative approach to ... [More Details]
Study results articleYes Evans HE, Forbes CC, Galvão DA, Vandelanotte C, Ne... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUsability, acceptability, and safety analysis of a computer-tailored web-based exercise intervention (exerciseguide) for individuals with metastatic prostate cancer: Multi-methods laboratory-based study.2021https://dx.doi.org/10.2196/28370
N.B. These documents automatically identified may not have been verified by the study sponsor.