Physical Activity for Adults in the Ontario Breast Screening Program
NCT ID: NCT06405568
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-02-01
2027-02-01
Brief Summary
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Detailed Description
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Efforts to promote PA in adults at higher-than-average risk for breast cancer (reflected by their enrollment in the Ontario Breast Screening Program), are critical to reduce their risk of breast cancer. Despite the effectiveness of PA recommendations delivered through health care providers (HCPs), most individuals do not receive them during routine care as HCPs report barriers to promoting PA (e.g., inadequate training, lack of time/knowledge). Research needs to focus on developing sustainable interventions that can be implemented broadly using distance-based approaches and available infrastructure (e.g., patient registries) without burdening HCPs to increase the consistency with which PA is promoted to adults at higher-than-average risk for breast cancer. Unlike self-guided PA interventions, supervised face-to-face PA interventions can be costly, unsustainable, and have limited ability to reach individuals unable (or unwilling) to travel to a facility where interventions are delivered. Thus, online interventions should be explored as a means to expand support to adults at higher-than-average risk for breast cancer, as a complement to offering PA recommendations. When self-guided, these interventions are easily scalable at a relatively low marginal cost per additional participant. When self-guided, these interventions are easily scalable at a relatively low marginal cost per additional participant, accessible, self-paced, and available around the clock. Accordingly, they are frequently valued for their accessibility and convenience. Additionally, as interventions incorporating behaviour change techniques, such as goal setting and problem-solving, show greater sustained PA levels post-intervention, it is critical to embed those evidence-based techniques and PA materials (e.g., printed materials, logbook, webinars and education sessions) into online interventions if they are to be effective.
Accordingly, this team of researchers and HCPs have partnered to develop and evaluate an intervention comprising of a copy of PA recommendations for adults (18-64 years) plus a motivation package (intervention arm) that can be implemented using a distance-based approach and sustained in the current healthcare system without burdening HCPs. This study aims to test the following hypothesis: the effects of the intervention on PA (primary outcome), quality of life (QoL) (secondary outcome), and body mass index (BMI; secondary outcome) in adults at high-risk of breast cancer will be greater in comparison to standard care plus a copy of PA recommendations for adults (control arm).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Physical activity recommendations plus motivation package (Intervention Arm)
Participants randomized to the intervention arm will receive a package consisting of two components: (1) a copy of age-appropriate physical activity (PA) recommendations matching the Canadian Society of Exercise Physiology (CSEP) recommendations and spotlighting PA benefits, and (2) a PA motivation package including: (a) a link to a website to view three 20-minute webinars covering PA benefits (for cancer risk reduction, quality of life, and weight management) and how to get started using the digitized PA materials and logbook, (b) digitized PA materials containing information explaining and supporting PA recommendations, examples of easy and safe PA participation for all, and activity sheets on behaviour change tools for sustaining PA, and (c) a PA logbook with instructions on how to track PA and tips for increasing PA.
Physical activity intervention
Participants will receive a copy of physical activity (PA) recommendations plus a PA motivation package - namely three 20-minute online webinars (explaining PA benefits and how to get started), digitized PA materials (integrating evidence-based behaviour change tools, and a digitized logbook (to track PA).
Standard care and physical activity recommendations (Control Arm)
Participants randomized to the control arm will receive standard care (medical consultations/monitoring at the discretion of each patient's care team) and be advised to continue regular daily living activities; physical activity (PA) restrictions will not be imposed. To facilitate trial retention and because contamination could occur as control arm participants' care team may recommend PA as part of their practice, participants will receive a copy of age-appropriate PA recommendations matching the Canadian Society of Exercise Physiology (CSEP) recommendations and spotlighting PA benefits. This further helps to mitigate the risk that knowledge of which arm a participant has been allocated to leads to moral demoralization in control arm participants. The control arm participants will receive the PA motivation package post-study completion to encourage study completion.
No interventions assigned to this group
Interventions
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Physical activity intervention
Participants will receive a copy of physical activity (PA) recommendations plus a PA motivation package - namely three 20-minute online webinars (explaining PA benefits and how to get started), digitized PA materials (integrating evidence-based behaviour change tools, and a digitized logbook (to track PA).
Eligibility Criteria
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Inclusion Criteria
* Aged 30-69 years;
* Assigned female at birth;
* Be at high risk for breast cancer as identified through Category A or B, after genetic assessment: (a) Category A individuals meet ≥1 of the following criteria: (i) known carrier of a gene mutation (e.g., BRCA1, BRCA2), (ii) first degree relative of a carrier of a gene mutation (e.g., BRCA1, BRCA2), received genetic counselling but declined genetic testing, (iii) previously assessed as having ≥25% lifetime risk of breast cancer on basis of family history, or (iv) received chest radiation before age 30 and ≥ 8 years previously.
(b) Category B individuals meet ≥1 of the following criteria: (i) first degree relative of a carrier of a gene mutation (e.g., BRCA1, BRCA2), has not had genetic counselling or testing, (ii) a personal or family history of ≥1 of the following: ≥2 cases of breast cancer and/or ovarian cancer in closely related blood relatives, bilateral breast cancer, both breast cancer and ovarian cancer in the same individual, breast cancer at age ≤35 years, invasive serous ovarian cancer, breast cancer and/or ovarian cancer in Ashkenazi Jewish families, an identified gene mutation (e.g., BRCA1, BRCA2) in any blood relative, male breast cancer.
Exclusion Criteria
* \>150 minutes of moderate-to-vigorous intensity physical activity in the past week;
* no access to an internet connected device;
* a condition preventing physical activity (e.g., uncontrolled hypertension)
30 Years
69 Years
FEMALE
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canadian Cancer Society (CCS)
OTHER
University of Ottawa
OTHER
Responsible Party
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Jennifer Brunet
Full Professor
Principal Investigators
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Jennifer Brunet, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Central Contacts
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References
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Friedenreich CM, Ryder-Burbidge C, McNeil J. Physical activity, obesity and sedentary behavior in cancer etiology: epidemiologic evidence and biologic mechanisms. Mol Oncol. 2021 Mar;15(3):790-800. doi: 10.1002/1878-0261.12772. Epub 2020 Aug 18.
McTiernan A, Friedenreich CM, Katzmarzyk PT, Powell KE, Macko R, Buchner D, Pescatello LS, Bloodgood B, Tennant B, Vaux-Bjerke A, George SM, Troiano RP, Piercy KL; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity in Cancer Prevention and Survival: A Systematic Review. Med Sci Sports Exerc. 2019 Jun;51(6):1252-1261. doi: 10.1249/MSS.0000000000001937.
McTiernan A, Schwartz RS, Potter J, Bowen D. Exercise clinical trials in cancer prevention research: a call to action. Cancer Epidemiol Biomarkers Prev. 1999 Mar;8(3):201-7.
Patel AV, Friedenreich CM, Moore SC, Hayes SC, Silver JK, Campbell KL, Winters-Stone K, Gerber LH, George SM, Fulton JE, Denlinger C, Morris GS, Hue T, Schmitz KH, Matthews CE. American College of Sports Medicine Roundtable Report on Physical Activity, Sedentary Behavior, and Cancer Prevention and Control. Med Sci Sports Exerc. 2019 Nov;51(11):2391-2402. doi: 10.1249/MSS.0000000000002117.
Hebert ET, Caughy MO, Shuval K. Primary care providers' perceptions of physical activity counselling in a clinical setting: a systematic review. Br J Sports Med. 2012 Jul;46(9):625-31. doi: 10.1136/bjsports-2011-090734.
Haines TP, Sinnamon P, Wetzig NG, Lehman M, Walpole E, Pratt T, Smith A. Multimodal exercise improves quality of life of women being treated for breast cancer, but at what cost? Randomized trial with economic evaluation. Breast Cancer Res Treat. 2010 Nov;124(1):163-75. doi: 10.1007/s10549-010-1126-2. Epub 2010 Aug 24.
Ormel HL, van der Schoot GGF, Sluiter WJ, Jalving M, Gietema JA, Walenkamp AME. Predictors of adherence to exercise interventions during and after cancer treatment: A systematic review. Psychooncology. 2018 Mar;27(3):713-724. doi: 10.1002/pon.4612. Epub 2018 Jan 26.
Sevick MA, Dunn AL, Morrow MS, Marcus BH, Chen GJ, Blair SN. Cost-effectiveness of lifestyle and structured exercise interventions in sedentary adults: results of project ACTIVE. Am J Prev Med. 2000 Jul;19(1):1-8. doi: 10.1016/s0749-3797(00)00154-9.
Brunet J, Wurz A, Nader PA, Belanger M. A systematic review summarizing the effect of health care provider-delivered physical activity interventions on physical activity behaviour in cancer survivors. Patient Educ Couns. 2020 Jul;103(7):1287-1301. doi: 10.1016/j.pec.2020.02.002. Epub 2020 Feb 8.
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.
Related Links
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Physical Activity and Health Promotion Laboratory Official Website
Other Identifiers
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156827
Identifier Type: -
Identifier Source: org_study_id