Recruiting

Sedentary Behaviour

Sponsor:

University of Toronto

Code:

NCT05214937

Conditions

Sedentary Behavior

Cancer of Prostate

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention

FitBit Only

Study Details

Brief summary:

This randomized controlled trial (RCT) will aim to examine the effect of a 12-week behavioural intervention on changing the sedentary behaviours (SB) of prostate cancer survivors (PCS) compared to a control group (FitBit-only group). PCS in the intervention group will receive a FitBit and 6 behavioural support sessions with a movement specialist guided by behavioural theory (i.e., the Multi-Process Action Control \[M-PAC\]). The FitBit-only group will only receive a FitBit and access to public health resources on physical activity (PA). The primary purpose of this study is to determine the efficacy of the intervention on changing SB of PCS immediately following the 12-week intervention and 6-months later. It is hypothesized that that the intervention will decrease their SB compared to the FitBit-only control condition at both timepoints. This trial will also examine the effect of the intervention on changing PA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function, quality of life, fatigue, disability and mental health compared to the active control condition.

Conditions

Sedentary Behavior

Cancer of Prostate

Study ID

NCT05214937

Start date

Feb 15, 2022

Status verified date

Dec, 2024

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • >= 18 years of age
  • 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:

  • Not planning to live in Canada for the next 12 months
  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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).

Interventions

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.

Primary outcome measure

  • Change in sedentary behaviour as assessed by activPAL inclinometers [ Time Frame: Baseline, Post-Intervention (12-weeks), 6-month Follow Up ]

Central Contacts and Locations

Central contacts

Linda Trinh, PhD

416-946-3624linda.trinh@utoronto.ca

Locations

University of Toronto

Recruiting

Toronto, Ontario, Canada, M5S 2W6

Contacts

Linda Trinh, PhD

4169465856linda.trinh@utoronto.ca

More Information

Sponsor

University of Toronto

Last update posted

Dec 4, 2024

Last verified

Dec, 2024

Keywords

  • distance-based
  • sedentary behavior
  • physical activity
  • cancer survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2024-12-04.