Intervention for Prostate Cancer

University of Toronto, Toronto, Canada
Prostate Cancer+1 More ConditionsIntervention - Behavioral
Eligibility

Study Summary

This trial will examine the effect of a 12-week behavioural intervention on changing sedentary behaviours of prostate cancer survivors compared to a control group.

Eligible Conditions
  • Prostate Cancer
  • Sedentary Lifestyle

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline, Post-Intervention (12-weeks), 6-month Follow Up

Baseline
Internet & Technology Use as assessed by the eHEALS eHealth literacy scale
Baseline, Post-Intervention (12-weeks), 6-month Follow Up
Change in Disease-Specific Quality of Life as assessed by the Functional Assessment of Cancer Therapy
Change in Health & Disability as assessed by the WHODAS 2.0
Change in Health-related Quality of Life as assessed by the Short Form-12
Change in Mental Health as assessed by the Hospital Anxiety and Depression Scale
Change in Objectively-assessed Physical Activity as assessed by activPAL inclinometers
Change in Reflective Motivational Processes
Change in Reflexive Motivational Processes
Change in Regulatory Motivational Processes
Change in Self-Reported Physical Activity assessed by the Godin Leisure Time Exercise Questionnaire
Change in Self-reported Sedentary Behaviour as assessed by the Longitudinal Aging Study Amsterdam
Sedentary lifestyle
Physical Function as assessed by the 30 second sit to stand
Post-Intervention (12-weeks)
Program Feedback

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Fitbit Only
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: Intervention · Intervention Types: Behavioral
Fitbit Only
Behavioral
ActiveComparator Group · 1 Intervention: FitBit Only · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention
2011
Completed Phase 4
~73850

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post-intervention (12-weeks), 6-month follow up

Who is running the clinical trial?

University of TorontoLead Sponsor
648 Previous Clinical Trials
733,445 Total Patients Enrolled
8 Trials studying Prostate Cancer
1,237 Patients Enrolled for Prostate Cancer
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,268 Previous Clinical Trials
25,601,071 Total Patients Enrolled
7 Trials studying Prostate Cancer
1,536 Patients Enrolled for Prostate Cancer
Linda Trinh, PhDPrincipal InvestigatorUniversity of Toronto
3 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Prostate Cancer
27 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are not mentally prepared or motivated to make changes related to the study.
You are not currently receiving radiation or chemotherapy treatments.
You do not get enough exercise - less than 150 minutes of moderate-to-vigorous physical activity per week.
References

Frequently Asked Questions

What is the aggregate headcount of participants in this trial?

"Affirmative. Information available on clinicaltrials.gov indicates that this medical trial commenced recruitment on February 15th 2022 and is still ongoing, with the most recent update posted April 15th 2022. The study requires 120 individuals to be enrolled at one centre of care." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities currently available for volunteers to join this experiment?

"Affirmative. Clinicaltrials.gov's records show that this medical research was initially posted on February 15th 2022 and it is currently searching for 120 participants from one location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.