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Trial registered on ANZCTR


Registration number
ACTRN12618001743257
Ethics application status
Approved
Date submitted
18/10/2018
Date registered
23/10/2018
Date last updated
23/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS) using Wearable technology and telephone health-coaching: Randomised Controlled Trial
Scientific title
Promoting Physical Activity in Australian Regional and Remote Cancer Survivors (PPARCS) using Wearable technology and telephone health-coaching: Randomised Controlled Trial
Secondary ID [1] 296371 0
None
Universal Trial Number (UTN)
U1111-1222-5698
Trial acronym
PPARCS (Promoting Physical Activity in Regional/Remote Cancer Survivors)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer survivors 310109 0
Condition category
Condition code
Cancer 308853 308853 0 0
Bladder
Cancer 308854 308854 0 0
Bowel - Anal
Cancer 308855 308855 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 308856 308856 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 308857 308857 0 0
Breast
Cancer 308858 308858 0 0
Prostate
Cancer 308859 308859 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include (I) providing a wearable tracker; (ii) up to six individual telephone or social media based sessions of health coaching. and (iii) a booklet with physical activity information and motivational tools to support behaviour change. The wearable tracker will be a wrist worn Fitbit Charge 2. Participants will be encouraged to wear the Fitbit during all waking hours, except for showering or swimming. However, it is not mandatory to wear the Fitbit during all waking hours. Participants will choose mode of delivery according to their preferences from a choice of telephone, Skype, zoom, or messenger etc. This is a distance-based intervention. Therefore the wearable tracker will be mailed to participants. Four sessions of health coaching are fixed (at wk 1, 2, 4 and 8) for all participants and will last up to 45 minutes each. However, the intervention includes a patient-centred and stepped-care approach by providing additional health coaching sessions (i.e., at wk 6, and 10) to those who may need them in order to achieve meaningful sustained physical activity change. A Health coach will be employed to deliver the intervention and will be required to have a background in Psychology or allied health discipline (at least to degree level), and previous experience of interviewing or working with patients. There is no specific exercise prescription but participants will be encouraged to meet the physical activity guidelines for cancer survivors, which is at least 150 minutes of moderate-intensity physical activity per week. They will also be informed that 3-5 hours of moderate-intensity physical activity will bring maximum benefits and will be encouraged to reach this goal once achieve the minimum guidelines of 150-minutes per week.

The purpose of the health coaching is to motivate and support increased physical activity through supporting self-efficacy, action planning, and coping planning. The first session will cover technical issues and features of the Fitbit and physical activity recommendations. It will also foster positive outcome expectancies and confidence towards physical activity and guide the participant to create physical activity action plans. The purpose of the three-five follow-up sessions will be to provide support, problem solving, and help the participant to update goals and action plans as they progress.
Intervention code [1] 312704 0
Lifestyle
Intervention code [2] 312705 0
Behaviour
Comparator / control treatment
The control group will receive only the booklet with physical activity information and motivational tools to support behaviour change.

The motivational tools include action planning, goal setting, self-monitoring, confidence building and coping planning and these tools are found in the booklet in the form of worksheets.
Control group
Active

Outcomes
Primary outcome [1] 307830 0
The primary outcome is Minutes of Moderate to vigorous physical activity per week assessed using an accelerometer (the Actigraph GT9 X). At each assessment point, participants will be mailed the Actigraph and asked to wear the device on their hip or waist for a period of 7 consecutive days during all waking hours.
Timepoint [1] 307830 0
week 12 post baseline assessment
Primary outcome [2] 307831 0
Change in minutes of sedentary behaviour per week, also assessed using the Actigraph GT9X . Sedentary behaviour will be defined by accelerometer activity counts of <100 counts per minute, for 20 consecutive minutes or more.
Timepoint [2] 307831 0
week24 post baseline assessment
Secondary outcome [1] 353074 0
Change in quality of life. Quality of life will be assessed using the medical outcomes short-form survey by Ware, Kosinski & Keller (1996).
Timepoint [1] 353074 0
week 12 post baseline assessment and week 24 post baseline assessment

Eligibility
Key inclusion criteria
Participants will be recruited on the basis that they are 1) survivors of breast, colorectal, gynaecological or prostate cancer; and 2) reside in either a regional or remote area of Australia. Eligible participants must also be 1) insufficiently physically active (i.e., engaging in less than 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity per week) (Department of Health, 2014; Rock et al., 2012); 2) aged between 18 and 80 years; 3) proficient in English-reading and speaking; 4) have no known presence of cancer at the time of recruitment; 5) have internet access at home.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include individuals who 1) are still undergoing treatment for cancer except for maintenance therapy such as tamoxifen; 2) have known cardiac abnormalities including unstable angina or recent myocardial infarction; 3) have any severe disability that may affect physical function including severe arthritis; 4) have a current diagnosis of a severe psychiatric illness (those with minor psychiatric diagnoses will be eligible if they are well enough to participate; 5) are currently enrolled in a health behaviour trial or program.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The statistician will generate the randomisation sequence using STATA v15 with a 1:1 allocation using random block sizes of 4 and 6 to support allocation concealment. Participant allocation will be implemented using sequentially numbered, opaque sealed envelopes, and the researchers involved in assessing and enrolling participants will not be involved in the generation of the randomisation sequence. Following consent and baseline assessment, the trial coordinator will choose the next envelope in the sequence and write the participant study number onto the envelope prior to allocating the participant to that group. Carbon paper inside the envelope will transfer the number onto the card containing the details of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The statistician will generate the randomisation sequence using STATA v15 with a 1:1 allocation using random block sizes of 4 and 6 to support allocation concealment. Participant allocation will be implemented using sequentially numbered, opaque sealed envelopes, and the researchers involved in assessing and enrolling participants will not be involved in the generation of the randomisation sequence. Following consent and baseline assessment, the trial coordinator will choose the next envelope in the sequence and write the participant study number onto the envelope prior to allocating the participant to that group. Carbon paper inside the envelope will transfer the number onto the card containing the details of allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is change in MVPA. A sample size of 94 participants (47 in each arm) is required in order to achieve 80% power to detect a difference of 70 ± 120 minutes of MVPA per week between the arms at 0.05 level. Our calculations are based a previous trial in survivors using wearable trackers and Actigraphs to assess MVPA (WATAAP trial; Maxwell-Smith et al., 2018) where the observed net increase was 70 minutes (SD 120) of MVPA at 12-weeks.

Statistical Analysis
The effectiveness of the intervention vs. control on Moderate to vigorous physical activity (MVPA) a week (the primary outcome) will be assessed using a linear mixed model, with group (intervention vs. control), time (T1 vs. T2 and T3) and their interaction as fixed effects, and with a random effect for participant included to account for the correlations in observations inherent in a repeated measures design. Age, gender, baseline physical activity level, adjuvant therapy, cancer type, months since diagnosis, and intervention dose will be considered as covariates in the model. Groups will also be compared on secondary outcomes (waist circumference, quality of life) and Health action Process Approach constructs using mixed models, including adjustment for confounding where appropriate. Intention-to-treat analysis will be conducted where there is attrition of participants from the trial. Appropriate longitudinal mediation models will be used to investigate whether a) intervention associated changes in MVPA are mediated (at least partially) via the Health Action Process Approach Model and b) changes in QoL are partially mediated via changes in MVPA. All data will be analysed using STATA with p <0.05 considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2019
Actual
Date of last participant enrolment
Anticipated
2/09/2019
Actual
Date of last data collection
Anticipated
6/03/2020
Actual
Sample size
Target
94
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12207 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [2] 12208 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [3] 12209 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 24385 0
6008 - Subiaco
Recruitment postcode(s) [2] 24386 0
6150 - Murdoch
Recruitment postcode(s) [3] 24387 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 300975 0
Charities/Societies/Foundations
Name [1] 300975 0
The Tonkinson Colorectal CancerResearch Fund
Country [1] 300975 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Tonkinson Colorectal CancerResearch Fund
Address
St John of God Hospital
12 Salvado Road
Subiaco
Perth
6008
WA
Country
Australia
Secondary sponsor category [1] 300556 0
University
Name [1] 300556 0
Curtin University
Address [1] 300556 0
School of Psychology
Curtin University,
PO Box U1987
Perth
Western Australia, 6845
Country [1] 300556 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301737 0
St John of God Healthcare Human Research Ethics Committee
Ethics committee address [1] 301737 0
Ethics committee country [1] 301737 0
Australia
Date submitted for ethics approval [1] 301737 0
17/05/2017
Approval date [1] 301737 0
28/07/2017
Ethics approval number [1] 301737 0
1201

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

Contacts
Principal investigator
Name 87942 0
Dr Sarah Hardcastle
Address 87942 0
School of Psychology
Curtin University,
PO Box U1987
Perth
Western Australia, 6845
Country 87942 0
Australia
Phone 87942 0
+61 439 226 015
Fax 87942 0
Email 87942 0
[email protected]
Contact person for public queries
Name 87943 0
Sarah Hardcastle
Address 87943 0
School of Psychology
Curtin University,
PO Box U1987
Perth
Western Australia, 6845
Country 87943 0
Australia
Phone 87943 0
+61 439 226 015
Fax 87943 0
Email 87943 0
[email protected]
Contact person for scientific queries
Name 87944 0
Sarah Hardcastle
Address 87944 0
School of Psychology
Curtin University,
PO Box U1987
Perth
Western Australia, 6845
Country 87944 0
Australia
Phone 87944 0
+61 439 226 015
Fax 87944 0
Email 87944 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbasePromoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: Randomised controlled trial protocol.2019https://dx.doi.org/10.1136/bmjopen-2018-028369
N.B. These documents automatically identified may not have been verified by the study sponsor.