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Behavioral Intervention for Reducing Sedentary Lifestyle in Prostate Cancer Survivors

N/A

Recruiting

Led By Linda Trinh, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently undergoing radiation or chemotherapy

No cardiac contraindications (e.g., unstable angina, arrhythmia, heart failure, aortic stenosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (12-weeks), 6-month follow up

Awards & highlights

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.

Who is the study for?

This trial is for prostate cancer survivors in Canada who are mostly inactive, sitting for over 8 hours a day, and not currently undergoing radiation or chemotherapy. They should be ready to start becoming more active, have no severe heart issues or walking disabilities, and must not have had a serious fall recently.Check my eligibility

What is being tested?

The study tests if a 12-week program with a FitBit and behavioral support sessions can reduce sedentary behavior in prostate cancer survivors compared to those just given a FitBit. It also looks at the program's impact on physical activity levels, motivation, sleep quality, social support, physical function, life quality, fatigue disability and mental health.See study design

What are the potential side effects?

There may be minimal side effects from participating in this intervention as it mainly involves increasing physical activity using a FitBit device. However general risks associated with increased activity might include muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently receiving radiation or chemotherapy.

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I do not have serious heart conditions like unstable chest pain or heart failure.

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I have prostate cancer that is either still within the prostate or has spread but isn’t causing symptoms.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (12-weeks), 6-month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (12-weeks), 6-month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (12-weeks), 6-month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sedentary lifestyle

Secondary outcome measures

Change in Objectively-assessed Physical Activity as assessed by activPAL inclinometers

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

Other outcome measures

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

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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.

Group II: Fitbit OnlyActive Control1 Intervention

Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living (e.g., 24-hour movement guidelines).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intervention

2011

Completed Phase 4

~73780

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

689 Previous Clinical Trials

1,018,523 Total Patients Enrolled

8 Trials studying Prostate Cancer

1,181 Patients Enrolled for Prostate Cancer

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,344 Previous Clinical Trials

26,453,297 Total Patients Enrolled

8 Trials studying Prostate Cancer

2,036 Patients Enrolled for Prostate Cancer

Linda Trinh, PhDPrincipal InvestigatorUniversity of Toronto

3 Previous Clinical Trials

66 Total Patients Enrolled

1 Trials studying Prostate Cancer

27 Patients Enrolled for Prostate Cancer

Media Library

Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05214937 — N/A

Prostate Cancer Research Study Groups: Intervention, Fitbit Only

Prostate Cancer Clinical Trial 2023: Intervention Highlights & Side Effects. Trial Name: NCT05214937 — N/A

Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05214937 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Recent research and studies

Evaluation & the Health ProfessionsJournal

General Population and Cancer Patient Norms for the Functional Assessment of Cancer Therapy-general (FACT-G)

Brucker, Penny S., Kathleen Yost, John Cashy, Kimberly Webster, and David Cella. 2005. “General Population and Cancer Patient Norms for the Functional Assessment of Cancer Therapy-general (FACT-G)”. Evaluation & the Health Professions. SAGE Publications. doi:10.1177/0163278705275341.

Medicine & Science in Sports & ExerciseJournal

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

CAMPBELL, KRISTIN L., KERRI M. WINTERS-STONE, JOACHIM WISKEMANN, ANNE M. MAY, ANNA L. SCHWARTZ, KERRY S. COURNEYA, DAVID S. ZUCKER, et al.. 2019. “Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable”. Medicine & Science in Sports & Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1249/mss.0000000000002116.

International Journal of Behavioral Nutrition and Physical ActivityJournal

Towards Parsimony in Habit Measurement: Testing the Convergent and Predictive Validity of an Automaticity Subscale of the Self-report Habit Index

Gardner, Benjamin, Charles Abraham, Phillippa Lally, and Gert-Jan de Bruijn. 2012. “Towards Parsimony in Habit Measurement: Testing the Convergent and Predictive Validity of an Automaticity Subscale of the Self-report Habit Index”. International Journal of Behavioral Nutrition and Physical Activity. Springer Science and Business Media LLC. doi:10.1186/1479-5868-9-102.

European Journal of Cancer CareJournal