Physical Activity for Adults in the Ontario Breast Screening Program

ConditionsBreast Cancer Female Physical Inactivity

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age30-69

SponsorUniversity of Ottawa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

>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)

Trial design

Design model

Parallel

Treatments tested in this trial

Physical activity intervention
Behavioral
Participants will receive a copy of physical activity (PA) recommendations plus a PA motivation package - namely three 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).

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Physical activity recommendations plus motivation package (Intervention Arm)Experimental treatment 1 intervention

Group B: Standard care and physical activity recommendations (Control Arm)No intervention 0 interventions

Trial outcomes

Primary outcomes

Physical activity (PA; aerobic)

PA will be measured using the Leisure Time Exercise Questionnaire (Godin \& Shephard, 1985). 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.

Time frame