Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000808246
Ethics application status
Approved
Date submitted
26/04/2018
Date registered
11/05/2018
Date last updated
10/03/2020
Date data sharing statement initially provided
10/03/2020
Date results provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Prostate Cancer Health and Fitness Online: A pilot randomised controlled trial investigating an online website for prostate cancer survivors to improve their physical activity
Scientific title
Prostate Cancer Health and Fitness Online: The use of computer-tailored web-based interventions for promoting physical activity among prostate cancer survivors: implications of design on feasibility, engagement and potential for efficacy.
Secondary ID [1] 294696 0
None
Universal Trial Number (UTN)
Trial acronym
PCHF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 307608 0
Condition category
Condition code
Cancer 306663 306663 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 3 armed pilot randomised controlled trial, randomised in 1:2:2 in blocks of 6 by a computer generator.

Arm 1: Tunneled computer-tailored website: 4 modules delivered weekly for 4 weeks.

Participants allocated to this group will have access to a computer-tailored intervention containing modules that are delivered sequentially and unlocked over time as each module is completed over a 4 week period. The modules will be designed to encourage participation in physical activity by influencing key determinants of physical activity behaviour, as per Social Cognitive Theory. Four modules will be developed and delivered over 4 weeks. The participants in the tunneled group will be asked to complete one module a week and to record their activity over the week until the next module is unlocked.

Each module will take approximately 20 min, with opportunities for more interaction if the participant desires. We will have a 'library' tab of the website where participants can find articles regarding prostate cancer and exercise evidence, and access to videos of different resistance based exercises.

The modules focus on increasing knowledge, building goals, facing and overcoming barriers, social support and building long-term physical activity habits. This group will have access to a page on the website where they can submit questions to an exercise physiologist. We will then generate a frequently asked questions section as part of the website. The exercise physiologist will have input over any advice in the tailored messages given by the program to ensure the advice is sound and appropriate. Participants will be monitored by website analytics: modules completed, sign-ins, number of minutes spent on the website. Participants will also be directed to current cancer exercise information as the wait list control.


Arm 2: Free-set-up computer-tailored modules: Participants allocated to this group will have access to the same computer-tailored modules as those allocated to the tunnelled condition. The difference is that all modules will be available from the beginning and can be completed in any order, Participants will be encouraged to interact with the site as little or as much as they like: the key here is to improve autonomy in terms of how participants interact. . Participants will be monitored by website analytics: modules completed, sign-ins, number of minutes spent on the website. Participants will also be directed to current cancer exercise information as the wait list control.
Intervention code [1] 301019 0
Lifestyle
Comparator / control treatment
Waitlist control.

Participants will be thanked for their time and directed to current cancer based physical activity web information (Cancer Council Australia and Prostate Cancer Foundation of Australia) . Participants will be informed that they will be able to access the intervention 4 weeks after their initial baseline activity survey has been completed.
Control group
Active

Outcomes
Primary outcome [1] 305679 0
Use: website analytics measuring the completion of physical activity module items
Timepoint [1] 305679 0
Items of module completion are measured throughout the 4-week intervention period.
Secondary outcome [1] 346143 0
the eHealth engagement score assesses participants self reported perceptions on 12 items regarding their interaction with a website. Assessed on a 5-point Likert scale participants are asked about if they found the site: Absorbing, Attention-Grabbing, Stimulating, Surprising, Suspenseful, Thought-Provoking, Clever, Convincing, Balanced, Believable, (Not) Dull and Hip/Cool

eHealth engagement scale: 12-items


Lefebvre RC, Tada Y, Hilfiker SW, Baur C. The Assessment of User Engagement with eHealth Content: The eHealth Engagement Scale. Journal of Computer-Mediated Communication. 2010 Jul 1;15(4):666-81
Timepoint [1] 346143 0
End of intervention: Within 24 hours of completing the final module.
Secondary outcome [2] 346145 0
Objective engagement with the website using website analytics: including the number of minutes spent on the website
Timepoint [2] 346145 0
End of intervention: Within 24 hours of completing the final module.
Secondary outcome [3] 346148 0
EORTIC- C30

2 items to assess the quality of life:

1) How would you rate your overall physical condition during the past week? and
2) How would you rate your overall quality of life during the past week?
Timepoint [3] 346148 0
Baseline: Before the participants get randomised and get access to the intervention: they must complete the baseline survey

End of intervention: Within 24 hours of completing the final module.
Secondary outcome [4] 346149 0
Self Efficacy: Task and behavioural based constructs based on Social Cognitive Theory and previous literature.

The scales have been built for this program using the reference points provided: non-valid measure but specific for the project


Bandura, Albert. "Guide for constructing self-efficacy scales." Self-efficacy beliefs of adolescents 5.1 (2006): 307-337.


Rogers LQ, Shah P, Dunnington G, Greive A, Shanmugham A, Dawson B, et al., editors. Social cognitive theory and physical activity during breast cancer treatment. Oncology nursing forum; 2005.

Short CE, James EL, Girgis A, Mcelduff P, Plotnikoff RC. Move more for life: the protocol for a randomised efficacy trial of a tailored-print physical activity intervention for post-treatment breast cancer survivors. BMC cancer. 2012;12(1):172.

Courneya KS, Plotnikoff RC, Hotz SB, Birkett NJ. Social support and the theory of planned behavior in the exercise domain. American Journal of Health Behavior. 2000;24(4):300-8.
Timepoint [4] 346149 0
Baseline: Before the participants get randomised and get access to the intervention: they must complete the baseline survey

End of intervention: Within 24 hours of completing the final module.
Secondary outcome [5] 346150 0
The System Usability Scale

10 questions 5 point likert scale from strongly disagree to strongly agree, the SUS asked general questions of usability. This is designed to assess the perceived usability of the website from the participants perspective using a validated tool

For example, please look at 3 items below.

1. I think that I would like to
use this system frequently

2. I found the system unnecessarily
complex


3. I thought the system was easy
to use

4. I think that I would need the
support of a technical person to
be able to use this system


10-item system usability scale (SUS)

Brooke, John. "SUS-A" quick and dirty" usability scale, Digital Equipment Co." (1986).
Timepoint [5] 346150 0
End of intervention: Within 24 hours of completing the final module.
Secondary outcome [6] 346151 0
Designed specifically for this study: .6 questions evaluating the perceptions of the exercise physiologist incorporated within the intervention. This will be measured using Likert scales and open-ended boxes. For example "Did you use the 'Ask and Expert' function of the website?"
Timepoint [6] 346151 0
End of intervention: Within 24 hours of completing the final module.
Secondary outcome [7] 346543 0
Website analysis: Objective engagement with the website: number of visits
Timepoint [7] 346543 0
End of intervention: Within 24 hours of completing the final module.
Secondary outcome [8] 346544 0
Website analytics: Objective engagement with the website: number of pages opened
Timepoint [8] 346544 0
End of intervention: Within 24 hours of completing the final module.
Secondary outcome [9] 350040 0
Godin-Shephard Leisure-Time Physical Activity Questionaire (GSLTPAQ) will monitor minutes of light, moderate to vigorous activity
Timepoint [9] 350040 0
End of intervention: Within 24 hours of completing the final module.
Secondary outcome [10] 350149 0
Client Satisfaction Scale- 8 item: Acceptability of the intervention to be measured using the
Timepoint [10] 350149 0
24 hours after the final completion of the last module.

Eligibility
Key inclusion criteria
Participants must have been previously diagnosed with prostate cancer, have completed active prostate cancer treatment (e.g., surgery, radiotherapy), and currently be in remission. Participants will also be required to read and write fluently in English, not already be participating in 150 minutes of aerobic activity per week or more than 2 sessions of resistance-training, have access to a computer and the internet and have no medical contradictions to exercise. Men who have completed active treatment but are undergoing hormone treatment as a preventive measure are eligible
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men who have not received active treatment (such as those on active surveillance), who are awaiting or currently undertaking active treatment with curative intent, or who are currently living with advanced or metastatic cancer will not be eligible to participate

Study design
Purpose of the study
Treatment
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)
The computer program will randomise participations into a 1:2:2 ratio into the different arms of the intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE CALCULATIONS:: To detect feasibility, usability and acceptability issues with a 15% (or greater) probability of occurring, it is estimated that 19 participants (per group) are needed in order to be reasonably sure (with 95% confidence) the problem will be detected

See: Viechtbauer W, Smits L, Kotz D, Budé L, Spigt M, Serroyen J, Crutzen R A simple formula for the calculation of sample size in pilot studies. Journal of Clinical Epidemiology 68 (11):1375-1379. doi:10.1016/j.jclinepi.2015.04.014

To detect differences in intervention usage (a proxy measure of engagement and acceptability) between the two intervention groups it is estimated that 36 participants per (intervention) group will be required. This will allow us to detect a 1-unit difference in mean module completion rates between intervention groups (SD = 1.5), with 80% power and an alpha of .05.

Given this, we will aim to recruit 100 participants in total, that will be randomized into the control and intervention groups on a 1:2:2 basis (i.e., N = 20 in control, N = 40 intervention arm 1, N = 40 intervention arm 2). This will allow us to compare feasibility, acceptability and preliminary potential for efficacy across all groups, and compare differences in intervention engagement between the two intervention arms – regardless of loss to follow-up. The study is unlikely to be powered to detect between group differences in physical activity behavior change, unless between group differences are large (e.g., d = 0.06). This is consistent with the aims of the study and pilot studies in general – whereby the results will be used to inform the development of a fully powered RCT focusing on establishing the efficacy of the developed interventions (if warranted based on pilot findings).

PRIMARY ANALYSIS: The primary analysis will be conducted with all study completers, with sensitivity analyses conducted to explore the impact of missing data. ANOVA or ANCOVA (where adjustment for confounders is needed) will be used to explore between group differences, with a p-value of 0.05. Post-hoc test will then be conducted if significant differences are found. Differences between the two intervention groups will be explored using independent sample t-tests. Effect Size (Cohen's D) will be applied for the T-Test to determine preliminary efficacy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
10/09/2018
Date of last participant enrolment
Anticipated
30/10/2018
Actual
4/02/2019
Date of last data collection
Anticipated
30/11/2018
Actual
15/03/2019
Sample size
Target
100
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 10797 0
Tennyson Centre Day Hospital - Kurralta Park
Recruitment postcode(s) [1] 22537 0
5037 - Kurralta Park

Funding & Sponsors
Funding source category [1] 299302 0
Charities/Societies/Foundations
Name [1] 299302 0
Freemasons Foundation Centre for Men's Health
Country [1] 299302 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Freemasons Foundation Centre for Men's Health
Address
The Freemason Foundation Centre for Men's Health, School of Medicine, University of Adelaide, 254 North Terrace
The University of Adelaide
SA 5005 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 298569 0
University
Name [1] 298569 0
Dr Camille Short
Address [1] 298569 0
The Freemason Foundation Centre for Men's Health, School of Medicine, University of Adelaide, South Australian Health and Medical Research Institute (SAHMRI)
Level 7, PO Box 11060, Adelaide SA 5001
Country [1] 298569 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300213 0
Human Research Ethics Committee, University of Adelaide
Ethics committee address [1] 300213 0
Ethics committee country [1] 300213 0
Australia
Date submitted for ethics approval [1] 300213 0
05/05/2017
Approval date [1] 300213 0
02/05/2018
Ethics approval number [1] 300213 0
H-2017-101

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2667 2667 0 0
/AnzctrAttachments/374969-Amendment approval H-2017-101 Short.pdf (Ethics approval)

Contacts
Principal investigator
Name 82934 0
Ms Amy Finlay
Address 82934 0
Level 7, South Australian Health and Medical Research Insititute, Freemasons Foundation Centre for Men's Health, University of Adelaide, South Australian Health and Medical Research Institute (SAHMRI), PO Box 11060, Adelaide SA 5001
Country 82934 0
Australia
Phone 82934 0
+61 08 8128 4056
Fax 82934 0
Email 82934 0
[email protected]
Contact person for public queries
Name 82935 0
Amy Finlay
Address 82935 0
Level 7, South Australian Health and Medical Research Insititute, Freemasons Foundation Centre for Men's Health, University of Adelaide, South Australian Health and Medical Research Institute (SAHMRI), PO Box 11060, Adelaide SA 5001
Country 82935 0
Australia
Phone 82935 0
+61 08 8128 4056
Fax 82935 0
Email 82935 0
[email protected]
Contact person for scientific queries
Name 82936 0
Amy Finlay
Address 82936 0
Level 7, South Australian Health and Medical Research Insititute, Freemasons Foundation Centre for Men's Health, University of Adelaide, South Australian Health and Medical Research Institute (SAHMRI), PO Box 11060, Adelaide SA 5001
Country 82936 0
Australia
Phone 82936 0
+61 08 8128 4056
Fax 82936 0
Email 82936 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics does not have data sharing approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.