Clinical trial · Interventional
Physical Activity for Adults in the Ontario Breast Screening Program
Support for Physical Activity for Adults Registered in the Ontario Breast Screening Program: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is "strong" evidence that physical activity (PA) can reduce the risk of breast cancer (Bernstein, 2009; Kehm et al., 2020), which is important for individuals at higher-than-average risk due to their family history or genetic susceptibility. PA can also enhance quality of life (QoL), fitness, and surrogate markers (e.g., weight) linked to cancer prognosis (Ligibel et al., 2019; Patel et al., 2019). Despite this evidence, most adults are insufficiently active, meaning they do not meet Canadian recommendations of at least 150 minutes of PA each week (Statistics Canada, 2020). This study aims to develop materials that can help increase the number of adults at higher-than-average risk who meet PA recommendations, alongside improving QoL and body mass index (BMI; a measure of one's body weight-height ratio). Participants will include individuals assigned female at birth, aged 30-69 years, at high-risk of breast cancer registered in the Ontario Breast Screening Program who will be randomly assigned to receive (1) the intervention, which includes a copy of PA recommendations (Canadian Society for Exercise Physiology \[CSEP\] recommendations for adults plus content spotlighting PA benefits) plus a PA motivation package featuring three online webinars (explaining PA benefits and how to get started), digitized PA materials (providing evidence-based tools to modify behaviour), and a digitized logbook (to track PA) or (2) only a copy of PA recommendations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Physical Inactivity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical activity intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Physical activity recommendations plus motivation package (Intervention Arm)
- description
- 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 online 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.
- interventionNames
- Behavioral: Physical activity intervention
- type
- NO_INTERVENTION
- label
- Standard care and physical activity recommendations (Control Arm)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * English- and French-speaking adults enrolled in the Ontario Breast Screening Program; * Aged 30-69 years; * Assigned female sex 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: Individuals self-reporting * \>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)
References
Publications (25)
- BACKGROUNDNigg CR, Rossi JS, Norman GJ, Benisovich SV. Structure of decisional balance for exercise adoption. Annals of Behavioral Medicine. 1998;20:S211.
- BACKGROUNDWilson PM, Rodgers WM, Loitz CC, Scime G. "It's Who I Am… Really!'The importance of integrated regulation in exercise contexts 1. Journal of Applied Biobehavioral Research. 2006 Apr;11(2):79-104. doi: 10.1111/j.1751-9861.2006.tb00021.x.
- BACKGROUNDWilson PM, Rogers WT, Rodgers WM, Wild TC. The psychological need satisfaction in exercise scale. Journal of Sport and Exercise Psychology. 2006 Sep 1;28(3):231-51. doi: 10.1123/jsep.28.3.231
- BACKGROUNDMackinnon A, Jorm AF, Christensen H, Korten AE, Jacomb PA, Rodgers B. A short form of the Positive and Negative Affect Schedule: Evaluation of factorial validity and invariance across demographic variables in a community sample. Personality and Individual differences. 1999 Sep;27(3):405-16. doi: 10.1016/S0191-8869(98)00251-7
- BACKGROUNDLigibel JA, Basen-Engquist K, Bea JW. Weight Management and Physical Activity for Breast Cancer Prevention and Control. Am Soc Clin Oncol Educ Book. 2019 Jan;39:e22-e33. doi: 10.1200/EDBK_237423. Epub 2019 May 17. PMID 31099634
- BACKGROUNDStatistics Canada. Table 13-10-0096-13 Physical activity, self reported, adult, by age group [Data set]. Statistics Canada. 2020 Nov. https://doi.org/https://doi.org/10.25318/1310009601-eng
- BACKGROUNDKehm RD, Genkinger JM, MacInnis RJ, John EM, Phillips KA, Dite GS, Milne RL, Zeinomar N, Liao Y, Knight JA, Southey MC, Chung WK, Giles GG, McLachlan SA, Whitaker KD, Friedlander M, Weideman PC, Glendon G, Nesci S, Investigators K, Andrulis IL, Buys SS, Daly MB, Hopper JL, Terry MB. Recreational Physical Activity Is Associated with Reduced Breast Cancer Risk in Adult Women at High Risk for Breast Cancer: A Cohort Study of Women Selected for Familial and Genetic Risk. Cancer Res. 2020 Jan 1;80(1):116-125. doi: 10.1158/0008-5472.CAN-19-1847. Epub 2019 Oct 2. PMID 31578201
- BACKGROUNDBernstein L. Exercise and breast cancer prevention. Curr Oncol Rep. 2009 Nov;11(6):490-6. doi: 10.1007/s11912-009-0066-7.