Breast Cancer Female Clinical Trial
Official title:
Support for Physical Activity for Adults Registered in the Ontario Breast Screening Program: A Randomized Controlled Trial
There is "strong" evidence that physical activity (PA) can reduce the risk of breast cancer, 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 linked to cancer prognosis (e.g., weight). Despite this evidence, most individuals in this cohort are insufficiently active, meaning they do not meet Canadian recommendations of at least 150 minutes of PA each week. 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 20-minute 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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 69 Years |
Eligibility | Inclusion Criteria: - English- and French-speaking adults enrolled in the Ontario Breast Screening Program; - 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: 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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Ottawa | Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR) |
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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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical activity (PA; aerobic) | PA will be measured using the Leisure Time Exercise Questionnaire. The questionnaire includes questions on the frequency of light, moderate, and strenuous activities lasting more than 15 minutes during a typical seven-day period. Responses will be aggregated to arrive at one reported value reflecting PA. | Week 0 (baseline) survey and Week 6 survey | |
Primary | Physical activity (PA; strength) | Participants will be asked to report on their strength and resistance training using a questionnaire created by Principal Investigator Dr. Brunet. | Week 0 (baseline) survey and Week 6 survey | |
Secondary | Quality of life (QoL) | General QoL and specific domains of QoL (i.e., general health perceptions, physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal/emotional problems, emotional well-being, social functioning, energy/fatigue) will be assessed using the RAND 36-Item Short Form Health Survey. | Week 0 (baseline) survey and Week 6 survey | |
Secondary | Body Mass Index (BMI) | Self-report BMI will be computed using two self-reported values (i.e., body mass in kilograms and height in meters) with the following formula: kg/m^2. | Week 0 (baseline) survey and Week 6 survey |
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