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.
- Prostate Cancer
- Sedentary Lifestyle
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Baseline, Post-Intervention (12-weeks), 6-month Follow Up
Trial Safety
Phase-Based Safety
Awards & Highlights
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Male Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- 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.
- 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.
- LYNCH, B.M., D.W. DUNSTAN, E. WINKLER, G.N. HEALY, E. EAKIN, and N. OWEN. 2010. “Objectively Assessed Physical Activity, Sedentary Time and Waist Circumference Among Prostate Cancer Survivors: Findings from the National Health and Nutrition Examination Survey (2003-2006)”. European Journal of Cancer Care. Wiley. doi:10.1111/j.1365-2354.2010.01205.x.
- Djukanovic, Ingrid, Jörg Carlsson, and Kristofer Årestedt. 2017. “Is the Hospital Anxiety and Depression Scale (HADS) a Valid Measure in a General Population 65–80 Years Old? A Psychometric Evaluation Study”. Health and Quality of Life Outcomes. Springer Science and Business Media LLC. doi:10.1186/s12955-017-0759-9.
- KOZEY-KEADLE, SARAH, AMANDA LIBERTINE, KATE LYDEN, JOHN STAUDENMAYER, and PATTY S. FREEDSON. 2011. “Validation of Wearable Monitors for Assessing Sedentary Behavior”. Medicine & Science in Sports & Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1249/mss.0b013e31820ce174.
- Andrews, Gavin, Alice Kemp, Matthew Sunderland, Michael Von Korff, and Tevik Bedirhan Ustun. 2009. “Normative Data for the 12 Item WHO Disability Assessment Schedule 2.0”. Edited by Joseph S. Ross. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0008343.
- Cella, D F, D S Tulsky, G Gray, B Sarafian, E Linn, A Bonomi, M Silberman, S B Yellen, P Winicour, and J Brannon. 1993. “The Functional Assessment of Cancer Therapy Scale: Development and Validation of the General Measure.”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.1993.11.3.570.
- Gandek, Barbara, John E. Ware, Neil K. Aaronson, Giovanni Apolone, Jakob B. Bjorner, John E. Brazier, Monika Bullinger, et al.. 1998. “Cross-validation of Item Selection and Scoring for the SF-12 Health Survey in Nine Countries”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/s0895-4356(98)00109-7.
- LYDEN, KATE, SARAH KOZEY KEADLE, JOHN STAUDENMAYER, and PATTY S. FREEDSON. 2017. “The Activpaltm Accurately Classifies Activity Intensity Categories in Healthy Adults”. Medicine & Science in Sports & Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1249/mss.0000000000001177.
- Tudor-Locke, Catrine, Scott W. Ducharme, Elroy J. Aguiar, John M. Schuna Jr, Tiago V. Barreira, Christopher C. Moore, Colleen J. Chase, et al.. 2020. “Walking Cadence (steps/min) and Intensity in 41 to 60-year-old Adults: The Cadence-adults Study”. International Journal of Behavioral Nutrition and Physical Activity. Springer Science and Business Media LLC. doi:10.1186/s12966-020-01045-z.
- Tudor-Locke, Catrine, Ho Han, Elroy J Aguiar, Tiago V Barreira, John M Schuna Jr, Minsoo Kang, and David A Rowe. 2018. “How Fast Is Fast Enough? Walking Cadence (steps/min) as a Practical Estimate of Intensity in Adults: A Narrative Review”. British Journal of Sports Medicine. BMJ. doi:10.1136/bjsports-2017-097628.
- Visser, Marjolein, and Annemarie Koster. 2013. “Development of a Questionnaire to Assess Sedentary Time in Older Persons – a Comparative Study Using Accelerometry”. BMC Geriatrics. Springer Science and Business Media LLC. doi:10.1186/1471-2318-13-80.
- Amireault, Steve, Gaston Godin, Jason Lacombe, and Catherine M. Sabiston. 2015. “The Use of the Godin-shephard Leisure-time Physical Activity Questionnaire in Oncology Research: A Systematic Review”. BMC Medical Research Methodology. Springer Science and Business Media LLC. doi:10.1186/s12874-015-0045-7.
- Kurtze, Nanna, Vegar Rangul, Bo-Egil Hustvedt, and W Dana Flanders. 2008. “Reliability and Validity of Self-reported Physical Activity in the Nord-trøndelag Health Study — HUNT 1”. Scandinavian Journal of Public Health. SAGE Publications. doi:10.1177/1403494807085373.
- Rhodes, Ryan E., and Kerry S. Courneya. 2003. “Investigating Multiple Components of Attitude, Subjective Norm, and Perceived Control: An Examination of the Theory of Planned Behaviour in the Exercise Domain”. British Journal of Social Psychology. Wiley. doi:10.1348/014466603763276162.
- 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.
- Burrell, Alison M. G., Julia L. Allan, David M. Williams, and Marie Johnston. 2018. “What Do Self‐efficacy Items Measure? Examining the Discriminant Content Validity of Self‐efficacy Items”. British Journal of Health Psychology. Wiley. doi:10.1111/bjhp.12306.
- Rhodes, Ryan E., Chris M. Blanchard, and Deborah Hunt Matheson. 2006. “A Multicomponent Model of the Theory of Planned Behaviour”. British Journal of Health Psychology. Wiley. doi:10.1348/135910705x52633.
- Norman, Cameron D, and Harvey A Skinner. 2006. “Eheals: The Ehealth Literacy Scale”. Journal of Medical Internet Research. JMIR Publications Inc.. doi:10.2196/jmir.8.4.e27.
- 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.
- WARE, JOHN E., JR., MARK KOSINSKI, and SUSAN D. KELLER. 1996. “A 12-item Short-form Health Survey”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005650-199603000-00003.
- Zigmond, A. S., and R. P. Snaith. 1983. “The Hospital Anxiety and Depression Scale”. Acta Psychiatrica Scandinavica. Wiley. doi:10.1111/j.1600-0447.1983.tb09716.x.
- 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.
- Amireault S, Godin G, Lacombe J, Sabiston CM. The use of the Godin-Shephard Leisure-Time Physical Activity Questionnaire in oncology research: a systematic review. BMC Med Res Methodol. 2015 Aug 12;15:60. doi: 10.1186/s12874-015-0045-7. Erratum In: BMC Med Res Methodol. 2016;16:30.
- Djukanovic I, Carlsson J, Arestedt K. Is the Hospital Anxiety and Depression Scale (HADS) a valid measure in a general population 65-80 years old? A psychometric evaluation study. Health Qual Life Outcomes. 2017 Oct 4;15(1):193. doi: 10.1186/s12955-017-0759-9.
- Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Porreca A, Noale M, Artibani W, Bassi PF, Bertoni F, Bracarda S, Conti GN, Corvo R, Gacci M, Graziotti P, Magrini SM, Mirone V, Montironi R, Muto G, Pecoraro S, Ricardi U, Russi E, Tubaro A, Zagonel V, Crepaldi G, Maggi S; Pros-IT CNR study group. Disease-specific and general health-related quality of life in newly diagnosed prostate cancer patients: the Pros-IT CNR study. Health Qual Life Outcomes. 2018 Jun 13;16(1):122. doi: 10.1186/s12955-018-0952-5.
- 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.
- Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27.
- Rhodes RE, Blanchard CM, Matheson DH. A multicomponent model of the theory of planned behaviour. Br J Health Psychol. 2006 Feb;11(Pt 1):119-37. doi: 10.1348/135910705X52633.
- 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
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