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Trial registered on ANZCTR


Registration number
ACTRN12618001855213
Ethics application status
Approved
Date submitted
9/11/2018
Date registered
14/11/2018
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A peer support program for the long-term maintenance of physical activity and health outcomes in breast, prostate and colorectal cancer survivors
Scientific title
The PEER Study: Peer support for the maintenance of high intensity interval training and health in cancer survivors
Secondary ID [1] 296568 0
APP1132361
Universal Trial Number (UTN)
U1111-1222-8169
Trial acronym
PEER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 310355 0
Prostate Cancer 310356 0
Colorectal Cancer 310357 0
Condition category
Condition code
Cancer 309084 309084 0 0
Breast
Cancer 309085 309085 0 0
Bowel - Anal
Cancer 309086 309086 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 309087 309087 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 309088 309088 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled intervention will compare peer support versus no peer support. Prior to randomisation all participants will complete a 4-week training program, supervised by an Accredited Exercise Physiologist or equivalent. This initial program required 3 times per week using a high-intensity interval training protocol of 4x4min intervals at 85-95% HRpeak, with 3 minute active recovery bouts in between. This protocol is a total of 38 minutes in duration. The purpose of this period is to ensure all participants understand the exercise protocol and are able to complete it safely during the maintenance phase. Participants will then be randomised. Participants whom receive peer support will be paired with a peer supporter (a breast, prostate or colorectal cancer survivor) who have undergone training to provide specific support to their peers in the respect of building motivation, enhancing confidence and knowledge of practice and facilitating the enhancement of self-efficacy. This training is provided by Cancer Council Queensland's peer support team, whom have a program targeted at teaching 'how to peer support', specific for cancer patients and survivors. This training will be a 1-day long training. Peer supporters will provide support to their partner 3 times per week for a 12-month period. Peer supporters will be asked to contact their participant at least once per week face-to-face, with additional support provided by either phone, email, text or an additional face-to-face contact. There is no minimum requirements for how detailed these 3 contacts must be; however, peer supporters will keep a log of the date and type of contact given to their participant. Participants will be recruitment from the Brisbane area, with the intervention being run from the University of Queensland and partnered gyms in the wider Brisbane area.
Intervention code [1] 312872 0
Treatment: Other
Intervention code [2] 312873 0
Lifestyle
Intervention code [3] 312874 0
Behaviour
Comparator / control treatment
The intervention group will be compared to a control group: no peer support (i.e. no treatment)
Control group
Active

Outcomes
Primary outcome [1] 308052 0
Adherence to physical activity and exercise (composite outcome). Objectively measured using the Actigraph GT3X+ accelerometer and logbook. These measured will be assessed to understand globally adherence to physical activity/ exercise during the maintenance phase.
Timepoint [1] 308052 0
Participants will wear the waist worn device for 7 days immediately before each testing occasion. Testing time-points will be at baseline (prior to supervised training), following the 4-weeks supervised training (i.e. week 5), and at 3-, 6-, and 12- months (primary endpoint) following randomisation. The training logbook will be collected following the participants 12-month testing.
Secondary outcome [1] 353836 0
Cardiorespiratory fitness measured using a VO2peak test on a cycle ergometer (Lode Recumbant). Participants will progressively cycle to volitional fatigue, with breath by breath analysis using ParvoMedics TrueOne system.
Timepoint [1] 353836 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.
Secondary outcome [2] 353837 0
Quality of life assessed using the FACT-G and SF-36 questionnaires
Timepoint [2] 353837 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.
Secondary outcome [3] 353838 0
Cancer related fatigue measured using the FACT-F scale.
Timepoint [3] 353838 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.
Secondary outcome [4] 353839 0
Grip strength assessed using a dynamometer
Timepoint [4] 353839 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.
Secondary outcome [5] 353840 0
Psychological distress assessed using the BSI questionnaire
Timepoint [5] 353840 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.
Secondary outcome [6] 353841 0
Depression assessed using the PHQ-9 questionnaire
Timepoint [6] 353841 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation
Secondary outcome [7] 353842 0
Generalised anxiety assessed using the GAD-7
Timepoint [7] 353842 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.
Secondary outcome [8] 353843 0
Insomnia assessed using the ISI questionnaire
Timepoint [8] 353843 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.
Secondary outcome [9] 353844 0
Body composition assessed using a DXA scan. A full body scan will be used to assess bone density, body fat percentage and muscle mass. Additionally, a left hip and lumbar spine scan will be done to further assess bone density. These results will be assessed in combination (composite).
Timepoint [9] 353844 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.
Secondary outcome [10] 353845 0
Blood biomarkers assessed using blood sampling. The specific outcomes are not determined as it will take an exploratory approach. It is expected that inflammatory markers (i.e. IGF-1, IGF-2, IGFBP3, IL-6 and IL-8); cholesterol (i.e. total cholesterol and lipids), and relevant cancer-specific markers (i.e. PSA for prostate cancer) will be assessed.
Timepoint [10] 353845 0
Baseline, week 5 (following supervised training) and at 3-, 6- and 12 months following randomisation.

Eligibility
Key inclusion criteria
- Histologically confirmed breast, prostate and colorectal cancer
- Aged 18 years or older
- At least one-month post-cancer treatments and not intending undergoing any further treatment during the study period
- Free of any musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently performing >4 x/ month high intensity interval training
- Unable to travel to the training/ testing facilities
- Unable to give informed consent
- Participant is pregnant or becomes pregnant during the study period

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)
Allocation involved contacting the holder of the allocation schedule who was “off-site’ or at a central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An online simple randomiser was used to allocate participants to either group, while stratifying for age (>/<60years) and gender (male/female).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Unpublished data from our previous study (Devin et al., 2015) demonstrated that 4 weeks of HIIT increased cancer survivors (n=36) physical activity levels from 259±556 to 380±424 min of MVPA/week. This is an effect size of Cohen’s d=0.24. Based on the hypothesis that those in the peer support group will maintain these levels of physical activity within 10% of those achieved following 4 weeks of HIIT, and the non-peer support/usual care group will decrease back to baseline, a priori power calculation determined that a sample of n=188 (n=94 per group) would be needed to detect a minimum between group difference of 121±494 min/wk of MVPA, with 5 measurement points, 80% power and 5% alpha. To account for an anticipated dropout rate of 30% (i.e. failure to attend follow-up testing sessions), a target of 244 participants (n=122 per group) would be set for recruitment.
Random effects mixed modelling with Fisher’s least significant difference tests for post-hoc analyses will be used to compare mean changes in outcomes between groups at each assessment period, with time (0, 4, 12, 26 and 52 weeks) and group allocation (peer support or no peer support) as the fixed factors. A time x group interaction term will be used to formally test for differences between groups (alpha =0.05). Intention to treat and per protocol analyses will be performed.

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)
QLD
Recruitment postcode(s) [1] 24648 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 301146 0
Government body
Name [1] 301146 0
National Health and Medical Research
Address [1] 301146 0
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601

Country [1] 301146 0
Australia
Funding source category [2] 301147 0
Charities/Societies/Foundations
Name [2] 301147 0
Cancer Council Queensland
Address [2] 301147 0
553 Gregory Terrace, Fortitude Valley, QLD, 4006
Country [2] 301147 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Human Movement Studies Building (Building 26B), Blair Drive, The University of Queensland, St Lucia, QLD, 4072
Country
Australia
Secondary sponsor category [1] 300766 0
Charities/Societies/Foundations
Name [1] 300766 0
Cancer Council Queensland
Address [1] 300766 0
553 Gregory Terrace, Fortitude Valley, QLD, 4006
Country [1] 300766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301895 0
Bellberry Limited
Ethics committee address [1] 301895 0
129 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 301895 0
Australia
Date submitted for ethics approval [1] 301895 0
26/04/2016
Approval date [1] 301895 0
17/08/2016
Ethics approval number [1] 301895 0
2015-12-840

Summary
Brief summary
The purpose of this study is to determine whether a structured peer support program can improve exercise adherence and health-outcomes in breast, prostate and colorectal cancer survivors.

Who is it for?

You may be eligible for this study if you are an adult with confirmed breast, prostate or colorectal cancer, and are at least one month post-treatment completion for cancer.

Study details

All participants will undertake an initial 4-week supervised training phase, with 3 sessions per week of exercise with an accredited exercise physiologist or equivalent. Following the supervised phase, participants will enter a 1-year maintenance period where they will be asked to maintain 150 minutes of moderate intensity or 75 minutes of vigorous intensity or a combination, therefore meeting the Australian exercise oncology guidelines. Participants will be randomly assigned to either receive peer support or no peer support during the maintenance phase.

It is hoped that this research will help determine if a peer support program is effective in enhancing exercise adherence and long-term health outcomes in cancer survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88466 0
Miss Chloe Salisbury
Address 88466 0
School of Human Movement and Nutrition Sciences Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 88466 0
Australia
Phone 88466 0
+61 4282 456 33
Fax 88466 0
+61 7 3365 6877
Email 88466 0
chloe.salisbury@uq.edu.au
Contact person for public queries
Name 88467 0
Miss Chloe Salisbury
Address 88467 0
School of Human Movement and Nutrition Sciences Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 88467 0
Australia
Phone 88467 0
+61 4282 456 33
Fax 88467 0
+61 7 3365 6877
Email 88467 0
chloe.salisbury@uq.edu.au
Contact person for scientific queries
Name 88468 0
Miss Chloe Salisbury
Address 88468 0
School of Human Movement and Nutrition Sciences Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 88468 0
Australia
Phone 88468 0
+61 4282 456 33
Fax 88468 0
+61 7 3365 6877
Email 88468 0
chloe.salisbury@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results