A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors
NCT ID: NCT05214937
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-02-15
2026-12-01
Brief Summary
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Detailed Description
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It is important that behavioural interventions are informed by theory, as theory-driven approaches are crucial for facilitating the adoption and maintenance of behaviour change. The Multi-Process Action Control (M-PAC) framework, a theoretical framework developed from PA behaviour change research specifically, suggests a layered, progressive approach to behaviour change where an individual moves from intention formation to adoption of action control and onto maintenance of action control. Intention formation is predicated on initiating reflective processes (i.e., instrumental attitude and perceived capability). Reflective processes are hypothesized to influence intention formation and initiate regulatory processes to enact this intention (i.e., affective attitude and perceived opportunity). The translation of intention into PA (i.e., action control) is determined partially by regulatory processes (e.g., action planning, coping planning, self-monitoring, social support) during the initial adoption of the behaviour. Continuation of PA action control is thought to include the addition of reflexive processes (e.g., habit) for long-term PA maintenance. This is a useful approach for PA and SB behaviour change interventions as it highlights processes for several stages of change including adoption and maintenance.
Previously supervised interventions have demonstrated success in increasing PA behaviours among cancer survivors but, distance-based interventions make an attractive alternative as they have extended reach due to potentially easier access and lower cost. Wearable activity monitors (e.g., FitBit) have been a successful SB and PA self-management intervention tool for cancer survivors. A previous pilot study conducted by our research group examined the feasibility of an unguided mhealth application (RiseTx) for reducing SB and increasing MVPA among PCS undergoing androgen deprivation therapy (ADT). PCS were given an activity tracker, access to the RiseTx mhealth web application which deployed a range of behaviour change support tools to reduce SB, and a goal of increasing step counts by 3,000 daily steps above baseline levels over 12-weeks. The RiseTx mhealth application was successful in reducing device-measured SB by 455 minutes/week and increasing MVPA by 44 minutes/week, as well as increasing steps by 1535 between baseline and post-intervention. Building upon this successful pilot study, the current RCT will harness the many lessons learned during the implementation of the RiseTx mhealth application. As an extension of this prior work, this updated iSTRIDE intervention will provide additional synchronous behavioural support aligned with processes in the M-PAC framework through videoconferencing, to reduce SB.
The multi-site, two-arm RCT will test the efficacy of this updated intervention on changing SB and PA in PCS. The primary objective is to determine the effects of the 12-week intervention (i.e., FitBit + behavioural counselling) compared to a control condition (FitBit + public resources) in reducing sitting time in PCS. It is hypothesized that that the intervention group will decrease their SB compared to the FitBit-only control condition at post-intervention (12 weeks) and 6-month follow-up. Secondary objectives of this trial are to determine the effects of the intervention on secondary outcomes including changes in MVPA, LPA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function and patient reported outcomes (i.e., QoL, fatigue, disability and mental health) compared to the FitBit-only control condition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
They will attempt to book all 3 assessments with same research assistant outcome assessor who meets the following criteria:
* Are not a movement specialist delivering one-on-one behavioural counselling
* Are not a movement specialist delivering a group webinar
* Are not aware of participant's group allocation
Any cases of unblinding will be noted in a Protocol Deviation Log.
Study Groups
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Intervention
Participants will be provided with a FitBit Inspire 2 and assigned a movement specialist. They will be asked to monitor their daily steps over the 12-week intervention period. Participants will attend 6 remotely-delivered behaviour change sessions (4 one-on-one sessions with their movement specialist, 2 group-based webinars). Sessions will be delivered bi-weekly and last \~30 minutes.
Intervention
During the first two weeks (baseline), participants will be asked to maintain their regular movement routine to set a baseline daily average step count. Phases I-III will involve self-regulatory strategies (e.g., action planning), address reducing/interrupting sedentary time, and step counts. Participants will be encouraged to increase their steps by 1000 steps/day from the baseline phase during each subsequent phase (i.e., 3000 steps above baseline by Phase III). Phases IV-V will be a maintenance phase through which participants will be encouraged to maintain 3000 steps per day above baseline. The sessions will be grounded within the Multi-Process Action Control Framework and address perceived capability/opportunity and instrumental/affective attitudes. The 1-on-1 sessions will focus on regulation (action \& coping planning, social support, goal setting) and reflexive processing (self-regulation, habit). The final one on one session will be a booster session to revisit previous topics.
Fitbit Only
Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living (e.g., 24-hour movement guidelines).
FitBit Only
Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living. They will receive a FitBit orientation session with a movement specialist prior to the 12-week control period.
Interventions
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Intervention
During the first two weeks (baseline), participants will be asked to maintain their regular movement routine to set a baseline daily average step count. Phases I-III will involve self-regulatory strategies (e.g., action planning), address reducing/interrupting sedentary time, and step counts. Participants will be encouraged to increase their steps by 1000 steps/day from the baseline phase during each subsequent phase (i.e., 3000 steps above baseline by Phase III). Phases IV-V will be a maintenance phase through which participants will be encouraged to maintain 3000 steps per day above baseline. The sessions will be grounded within the Multi-Process Action Control Framework and address perceived capability/opportunity and instrumental/affective attitudes. The 1-on-1 sessions will focus on regulation (action \& coping planning, social support, goal setting) and reflexive processing (self-regulation, habit). The final one on one session will be a booster session to revisit previous topics.
FitBit Only
Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living. They will receive a FitBit orientation session with a movement specialist prior to the 12-week control period.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with localized or asymptomatic metastatic primary prostate cancer
* Not currently undergoing radiation or chemotherapy
* Proficient in English
* Not physically active (self report \<150 minutes of moderate-to-vigorous physical activity per week)
* Self-report \>8 hours of daily sedentary behaviour
* In the contemplation or preparation stage for motivational readiness to change as determined by the Stages of Change Questionnaire
* Access to a smartphone, tablet, or computer
* No cardiac contraindications (e.g., unstable angina, arrhythmia, heart failure, aortic stenosis)
* Medical clearance from a primary health care provider (if necessary)
* Currently residing in Canada
Exclusion Criteria
* A medical condition that prohibits walking (e.g., severe knee or hip arthritis)
* Presence of other primary or recurrent invasive cancer (i.e., other than non-melanoma skin cancer)
* Have had a prior fall within the last 12-months
* Use a gait aid device
18 Years
MALE
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of Toronto
OTHER
Responsible Party
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Linda Trinh
Assistant Professor
Principal Investigators
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Linda Trinh, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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University of Toronto
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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28981
Identifier Type: -
Identifier Source: org_study_id