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
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
Phase-Based 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: BehavioralFitbit Only
Behavioral
ActiveComparator Group · 1 Intervention: FitBit Only · Intervention Types: BehavioralTreatment
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
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- Trinh, Linda, Kelly P. Arbour-Nicitopoulos, Catherine M. Sabiston, Scott R. Berry, Andrew Loblaw, Shabbir M. H. Alibhai, Jennifer M. Jones, and Guy E. Faulkner. 2018. “Risetx: Testing the Feasibility of a Web Application for Reducing Sedentary Behavior Among Prostate Cancer Survivors Receiving Androgen Deprivation Therapy”. International Journal of Behavioral Nutrition and Physical Activity. Springer Science and Business Media LLC. doi:10.1186/s12966-018-0686-0.
- Yellen, Suzanne B., David F. Cella, Kimberly Webster, Carol Blendowski, and Edward Kaplan. 1997. “Measuring Fatigue and Other Anemia-related Symptoms with the Functional Assessment of Cancer Therapy (FACT) Measurement System”. Journal of Pain and Symptom Management. Elsevier BV. doi:10.1016/s0885-3924(96)00274-6.
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- Porreca, Angelo, the Pros-IT CNR study group, Marianna Noale, Walter Artibani, Pier Francesco Bassi, Filippo Bertoni, Sergio Bracarda, et al.. 2018. “Disease-specific and General Health-related Quality of Life in Newly Diagnosed Prostate Cancer Patients: The Pros-it CNR Study”. Health and Quality of Life Outcomes. Springer Science and Business Media LLC. doi:10.1186/s12955-018-0952-5.
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- Trinh, Linda, Catherine M. Sabiston, Shabbir M. H. Alibhai, Jennifer M. Jones, Kelly P. Arbour-Nicitopoulos, Daniel Santa Mina, Kristin Campbell, and Guy E. Faulkner. 2022. “A Distance-based, Randomized Controlled Trial for Reducing Sedentary Behavior Among Prostate Cancer Survivors: A Study Protocol”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-022-13218-5.
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- Trinh L, Arbour-Nicitopoulos KP, Sabiston CM, Berry SR, Loblaw A, Alibhai SMH, Jones JM, Faulkner GE. RiseTx: testing the feasibility of a web application for reducing sedentary behavior among prostate cancer survivors receiving androgen deprivation therapy. Int J Behav Nutr Phys Act. 2018 Jun 7;15(1):49. doi: 10.1186/s12966-018-0686-0. Erratum In: Int J Behav Nutr Phys Act. 2018 Dec 4;15(1):124.
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- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Brucker PS, Yost K, Cashy J, Webster K, Cella D. General population and cancer patient norms for the Functional Assessment of Cancer Therapy-General (FACT-G). Eval Health Prof. 2005 Jun;28(2):192-211. doi: 10.1177/0163278705275341. Erratum In: Eval Health Prof. 2005 Sep;28(3):370.
- Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. 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. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
- Tudor-Locke C, Han H, Aguiar EJ, Barreira TV, Schuna JM Jr, Kang M, Rowe DA. How fast is fast enough? Walking cadence (steps/min) as a practical estimate of intensity in adults: a narrative review. Br J Sports Med. 2018 Jun;52(12):776-788. doi: 10.1136/bjsports-2017-097628.
- Rhodes RE, Courneya KS. Investigating multiple components of attitude, subjective norm, and perceived control: an examination of the theory of planned behaviour in the exercise domain. Br J Soc Psychol. 2003 Mar;42(Pt 1):129-46. doi: 10.1348/014466603763276162.
- Linda Trinh 2022. "A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05214937.
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