A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

NCT05214937 | Recruiting

• 1 other identifier: 28981
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial (RCT) will aim to examine the effect of a 12-week behavioural intervention on changing the sedentary behaviours (SB) of prostate cancer survivors (PCS) compared to a control group (FitBit-only group). PCS in the intervention group will receive a FitBit and 6 behavioural support sessions with a movement specialist guided by behavioural theory (i.e., the Multi-Process Action Control \[M-PAC\]). The FitBit-only group will only receive a FitBit and access to public health resources on physical activity (PA). The primary purpose of this study is to determine the efficacy of the intervention on changing SB of PCS immediately following the 12-week intervention and 6-months later. It is hypothesized that that the intervention will decrease their SB compared to the FitBit-only control condition at both timepoints. This trial will also examine the effect of the intervention on changing PA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function, quality of life, fatigue, disability and mental health compared to the active control condition.

Conditions

Sedentary Behavior; Cancer of Prostate

Keywords

distance-based; sedentary behavior; physical activity; cancer survivorship

Outcome Measures

Primary Outcomes (1)

• Change in sedentary behaviour as assessed by activPAL inclinometers

  Objectively-assessed sedentary behaviour will be assessed with activPAL inclinometers. The activPALs will be waterproofed and participants will be asked to wear the device in the mid-line of their right thigh for 7 days (24 hours per day). Participants will complete a wear log to identify sleep and non-wear periods. Total daily minutes of sedentary behaviour will be collected from the devices.

  Baseline, Post-Intervention (12-weeks), 6-month Follow Up

Secondary Outcomes (3)

• Change in Self-reported Sedentary Behaviour as assessed by the Longitudinal Aging Study Amsterdam

  Baseline, Post-Intervention (12-weeks), 6-month Follow Up

• Change in Self-Reported Physical Activity assessed by the Godin Leisure Time Exercise Questionnaire

  Baseline, Post-Intervention (12-weeks), 6-month Follow Up

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

  Baseline, Post-Intervention (12-weeks), 6-month Follow Up

Other Outcomes (10)

• Change in Reflective Motivational Processes

  Baseline, Post-Intervention (12-weeks), 6-month Follow Up

• Change in Regulatory Motivational Processes

  Baseline, Post-Intervention (12-weeks), 6-month Follow Up

• Change in Reflexive Motivational Processes

  Baseline, Post-Intervention (12-weeks), 6-month Follow Up

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Intervention

Fitbit Only

ACTIVE COMPARATOR

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

Behavioral: FitBit Only

Interventions

Intervention BEHAVIORAL

During the first two weeks (baseline), participants will be asked to maintain their regular movement routine to set a baseline daily average step count. Phases I-III will involve self-regulatory strategies (e.g., action planning), address reducing/interrupting sedentary time, and step counts. Participants will be encouraged to increase their steps by 1000 steps/day from the baseline phase during each subsequent phase (i.e., 3000 steps above baseline by Phase III). Phases IV-V will be a maintenance phase through which participants will be encouraged to maintain 3000 steps per day above baseline. The sessions will be grounded within the Multi-Process Action Control Framework and address perceived capability/opportunity and instrumental/affective attitudes. The 1-on-1 sessions will focus on regulation (action \& coping planning, social support, goal setting) and reflexive processing (self-regulation, habit). The final one on one session will be a booster session to revisit previous topics.

Intervention

FitBit Only BEHAVIORAL

Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living. They will receive a FitBit orientation session with a movement specialist prior to the 12-week control period.

Fitbit Only

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 18 years of age
• Diagnosed with localized or asymptomatic metastatic primary prostate cancer
• Not currently undergoing radiation or chemotherapy
• Proficient in English
• Not physically active (self report \<150 minutes of moderate-to-vigorous physical activity per week)
• Self-report \>8 hours of daily sedentary behaviour
• In the contemplation or preparation stage for motivational readiness to change as determined by the Stages of Change Questionnaire
• 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

You may not qualify if:

• Not planning to live in Canada for the next 12 months
• A medical condition that prohibits walking (e.g., severe knee or hip arthritis)
• Presence of other primary or recurrent invasive cancer (i.e., other than non-melanoma skin cancer)
• Have had a prior fall within the last 12-months
• Use a gait aid device

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 2W6, Canada

RECRUITING

Related Publications (25)

• 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.

  PMID: 26264621 BACKGROUND

• Andrews G, Kemp A, Sunderland M, Von Korff M, Ustun TB. Normative data for the 12 item WHO Disability Assessment Schedule 2.0. PLoS One. 2009 Dec 17;4(12):e8343. doi: 10.1371/journal.pone.0008343.

  PMID: 20020047 BACKGROUND

• 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.

  PMID: 15851773 BACKGROUND

• Burrell AMG, Allan JL, Williams DM, Johnston M. What do self-efficacy items measure? Examining the discriminant content validity of self-efficacy items. Br J Health Psychol. 2018 Sep;23(3):597-611. doi: 10.1111/bjhp.12306. Epub 2018 Mar 8.

  PMID: 29520897 BACKGROUND

• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

  PMID: 31626055 BACKGROUND

• 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.

  PMID: 8445433 BACKGROUND

• 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.

  PMID: 28978356 BACKGROUND

• 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.

  PMID: 9817135 BACKGROUND

• Gardner B, Abraham C, Lally P, de Bruijn GJ. Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. Int J Behav Nutr Phys Act. 2012 Aug 30;9:102. doi: 10.1186/1479-5868-9-102.

  PMID: 22935297 BACKGROUND

• Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

  PMID: 4053261 BACKGROUND

• Kozey-Keadle S, Libertine A, Lyden K, Staudenmayer J, Freedson PS. Validation of wearable monitors for assessing sedentary behavior. Med Sci Sports Exerc. 2011 Aug;43(8):1561-7. doi: 10.1249/MSS.0b013e31820ce174.

  PMID: 21233777 BACKGROUND

• Lyden K, Keadle SK, Staudenmayer J, Freedson PS. The activPALTM Accurately Classifies Activity Intensity Categories in Healthy Adults. Med Sci Sports Exerc. 2017 May;49(5):1022-1028. doi: 10.1249/MSS.0000000000001177.

  PMID: 28410327 BACKGROUND

• Lynch BM, Dunstan DW, Winkler E, Healy GN, Eakin E, Owen N. Objectively assessed physical activity, sedentary time and waist circumference among prostate cancer survivors: findings from the National Health and Nutrition Examination Survey (2003-2006). Eur J Cancer Care (Engl). 2011 Jul;20(4):514-9. doi: 10.1111/j.1365-2354.2010.01205.x. Epub 2010 Jun 29.

  PMID: 20597954 BACKGROUND

• 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.

  PMID: 17213046 BACKGROUND

• 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.

  PMID: 29898750 BACKGROUND

• 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.

  PMID: 12713760 BACKGROUND

• 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.

  PMID: 16480559 BACKGROUND

• 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.

  PMID: 29880049 BACKGROUND

• 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.

  PMID: 29858465 BACKGROUND

• Tudor-Locke C, Ducharme SW, Aguiar EJ, Schuna JM Jr, Barreira TV, Moore CC, Chase CJ, Gould ZR, Amalbert-Birriel MA, Mora-Gonzalez J, Chipkin SR, Staudenmayer J. Walking cadence (steps/min) and intensity in 41 to 60-year-old adults: the CADENCE-adults study. Int J Behav Nutr Phys Act. 2020 Nov 10;17(1):137. doi: 10.1186/s12966-020-01045-z.

  PMID: 33168018 BACKGROUND

• Visser M, Koster A. Development of a questionnaire to assess sedentary time in older persons--a comparative study using accelerometry. BMC Geriatr. 2013 Jul 30;13:80. doi: 10.1186/1471-2318-13-80.

  PMID: 23899190 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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.

  PMID: 9095563 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• Trinh L, Sabiston CM, Alibhai SMH, Jones JM, Arbour-Nicitopoulos KP, Mina DS, Campbell K, Faulkner GE. A distance-based, randomized controlled trial for reducing sedentary behavior among prostate cancer survivors: a study protocol. BMC Public Health. 2022 Apr 28;22(1):855. doi: 10.1186/s12889-022-13218-5.

  PMID: 35484523 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Prostatic Neoplasms; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Linda Trinh, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Trinh, PhD

CONTACT

416-946-3624; linda.trinh@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not possible to blind participants to their group allocation. Coordinating RAs will be the primary individuals responsible for scheduling all data collection assessments. They will attempt to book all 3 assessments with same research assistant outcome assessor who meets the following criteria: * Are not a movement specialist delivering one-on-one behavioural counselling * Are not a movement specialist delivering a group webinar * Are not aware of participant's group allocation Any cases of unblinding will be noted in a Protocol Deviation Log.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomization will be performed using a stratified randomization scheme via REDCap. The sequence will be random permutated blocks of varying sizes, stratified by ADT use (ADT vs. no ADT). PCS will be assigned in a 1:1 ratio to one of two groups. Randomization codes will be kept in a pre-made digital file that is separate from other study records.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 31, 2022
• Study Start: February 15, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)