Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06405568

Not yet recruiting

Physical Activity for Adults in the Ontario Breast Screening Program

Interventional

Phase not listed

Sponsor: University of Ottawa

Last Updated: December 11, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Show Detailed Description

Treatment Category

Behavioral

Required Mutations

BRCA2, BRCA1

Trial Started

February 1, 2025

Last Updated by Sponsor

December 11, 2024

Estimated Completion

February 1, 2027

Contact Study

Name:Julia Hussien, PhD

Email:jhussien@uottawa.ca

Phone:613-562-5800

Name:Jennifer Brunet, PhD

Email:jennifer.brunet@uottawa.ca

Phone:613-562-5800

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)

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingDouble

Number to Enroll200

Arms & Interventions

Arms

Interventions

Type: Experimental

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 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.

Interventions:

Physical activity intervention

Outcome Measures

Primary Outcome Measures

Physical activity (PA; aerobic)Week 0 (baseline) survey and Week 6 survey

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.

Physical activity (PA; strength)Week 0 (baseline) survey and Week 6 survey

Participants will be asked to report on their strength and resistance training using a questionnaire created by Principal Investigator Dr. Brunet.

Secondary Outcome Measures

Quality of life (QoL)Week 0 (baseline) survey and Week 6 survey

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.

Body Mass Index (BMI)Week 0 (baseline) survey and Week 6 survey

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.