Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID05214937

A Distance-based, Randomized Controlled Trial for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

Led by University of Toronto · Updated on 2024-12-04

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Toronto

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a 12-week behavioral intervention designed to reduce sedentary behavior among prostate cancer survivors (PCS). The study compares this intervention, which includes FitBit use and six behavioral support sessions guided by the Multi-Process Action Control (M-PAC) framework, to a control group that receives only a FitBit and access to public health physical activity resources. The study aims to measure changes in sedentary behavior immediately after the intervention and six months later, while also assessing impacts on physical activity, motivation, sleep quality, social support, physical function, quality of life, fatigue, disability, and mental health. Participants in the intervention group receive a FitBit Inspire 2 and six remote behavior change sessions delivered bi-weekly by a movement specialist, including four one-on-one sessions and two group webinars. They will monitor daily steps and work to increase their baseline step count progressively across phases. The control group receives the same FitBit device and an orientation session but only access to publicly available active living resources without additional behavioral support. The intervention sessions focus on planning, goal setting, social support, and habit formation based on the M-PAC theoretical framework. During the study, participants will wear activPAL inclinometers to objectively measure changes in sedentary behavior and physical activity at baseline, after the 12-week intervention, and at a 6-month follow-up. Self-reported sedentary behavior and physical activity will also be assessed using validated questionnaires. Researchers will monitor motivational factors, sleep, social support, physical function, and patient-reported outcomes such as quality of life, fatigue, disability, and mental health. The total participation involves these assessments across the intervention and follow-up periods, with data collected remotely.

CONDITIONS

Brief Title

A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Diagnosed with localized or asymptomatic metastatic primary prostate cancer
  • Not currently undergoing radiation or chemotherapy
  • Proficient in English
  • Self-report less than 150 minutes of moderate-to-vigorous physical activity per week
  • Self-report more than 8 hours of daily sedentary behaviour
  • In the contemplation or preparation stage for motivational readiness to change
  • 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
Not Eligible

You will not qualify if you...

  • Not planning to live in Canada for the next 12 months
  • Medical condition prohibiting walking (e.g., severe knee or hip arthritis)
  • Presence of other primary or recurrent invasive cancer (except non-melanoma skin cancer)
  • Had a prior fall within the last 12 months
  • Use of a gait aid device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (remote or in-person) for eligibility assessment

Baseline Period

Duration - 2 weeks

Participants maintain their regular movement routine to establish baseline daily average step count.

1 baseline visit with movement specialist and FitBit orientation

Intervention

Duration - 12 weeks

Participants receive a 12-week behavioural intervention involving self-regulatory strategies to reduce sedentary behaviour and increase daily step counts, supported by 6 remotely-delivered sessions including one-on-one and group webinars.

Bi-weekly remotely-delivered sessions totaling 6 sessions (4 one-on-one and 2 group webinars)

Follow-up

Duration - 6 months post-intervention

Participants are assessed at 6 months after the intervention to evaluate the maintenance of behaviour changes.

1 follow-up assessment visit

Trial Site Locations

Total: 1 location

1

University of Toronto

Toronto, Ontario, Canada, M5S 2W6

Actively Recruiting

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Research Team

L

Linda Trinh, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

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Steve Amireault, Gaston Godin, Jason Lacombe...

https://pubmed.ncbi.nlm.nih.gov/26264621

Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable.

Kristin L Campbell, Kerri M Winters-Stone, Joachim Wiskemann...

https://pubmed.ncbi.nlm.nih.gov/31626055

Is the Hospital Anxiety and Depression Scale (HADS) a valid measure in a general population 65-80 years old? A psychometric evaluation study.

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Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment.

B Gandek, J E Ware, N K Aaronson...

https://pubmed.ncbi.nlm.nih.gov/9817135

Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index.

Benjamin Gardner, Charles Abraham, Phillippa Lally...

https://pubmed.ncbi.nlm.nih.gov/22935297