Physical Activity for Adults in the Ontario Breast Screening Program

April 23, 2026 updated by: Jennifer Brunet, University of Ottawa

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 (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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Considerable research (>500 studies) has examined the association between physical (in)activity and cancer incidence (Friedenreich et al., 2021; McTiernan et al., 2019; McTiernan et al., 1999; Patel et al., 2019). Reviews of observational studies have led to the conclusion that there is some evidence for a reduced risk of 11 different cancer sites when comparing the highest to the lowest levels of physical activity (PA; Friedenreich et al., 2021). Specifically, there is "strong" evidence that PA reduces the risk of bladder, breast, colon, endometrial, esophageal adenocarcinoma, and gastric cancers. As a result, public health agencies (e.g., Public Health Agency of Canada) promote PA as an important part of a healthy lifestyle and note that regular PA can help to reduce the risk of premature death and chronic diseases including breast cancer. The Canadian Society for Exercise Physiology (CSEP; https://csepguidelines.ca/guidelines/adults-18-64/) published recommendations for adults (aged 18-64) that include: (a) performing at least 150 minutes of moderate-to-vigorous intensity PA each week (i.e., activities that get your heart beating faster), (b) performing muscle strengthening activities at least twice a week, (c) limiting time spent sitting or laying down to 8 hours or less a day, and (d) achieving good quality and consistent sleep (i.e., 7 to 9 hours, with consistent bed and wake-up times).

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; Hébert et al., 2012). 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 (Haines et al., 2010; Ormel et al., 2018; Sevick et al., 2000). 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, 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 (Brunet et al., 2020).

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).

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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 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.
Behavioral: Physical activity intervention
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity (PA; aerobic)
Time Frame: Week 0 (baseline) survey and Week 6 survey
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.
Week 0 (baseline) survey and Week 6 survey
Physical activity (PA; strength)
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to report on their strength and resistance training over the past seven days using a questionnaire created by Principal Investigator Dr. Brunet.
Week 0 (baseline) survey and Week 6 survey

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QoL)
Time Frame: 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 (McHorney et al., 1994).
Week 0 (baseline) survey and Week 6 survey
Body mass index (BMI)
Time Frame: 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.
Week 0 (baseline) survey and Week 6 survey

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behaviour change technique use
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to report on their use of various evidence-based behaviour change techniques (BCTs; Michie et al., 2013) to change their physical activity behaviour in the past six weeks using a questionnaire developed by the research team.
Week 0 (baseline) survey and Week 6 survey
Positive and negative affect
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to report on their transient affective state in the past week by completing the Positive and Negative Affect Schedule (PANAS-SF; (Mackinnon et al., 1999; Watson et al., 1988).
Week 0 (baseline) survey and Week 6 survey
Mental health state: Depression
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to report on their mental health over the last two weeks using the Patient Health Questionnaire Depression Scale (PHQ-9; Kroenke et al., 2001).
Week 0 (baseline) survey and Week 6 survey
Mental healh state: Generalized anxiety
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to report on their mental health over the last two weeks using the Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006).
Week 0 (baseline) survey and Week 6 survey
Physical activity behavioural regulations
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participats wil be asked to complete the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3; Wilson et al., 2006a) that will be modified to the physical activity (PA) context to assess participants' motivation for PA.
Week 0 (baseline) survey and Week 6 survey
Basic psychological needs satisfaction
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to complete the Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson et al., 2006b) modified to the physical activity (PA) context to assess their basic psychological needs satisfaction in relation to PA.
Week 0 (baseline) survey and Week 6 survey
Social support
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to complete the Physical Activity and Social Support Scale (PASSS; Golaszewski & Batholomew, 2019) to assess their perceived social support in relation to physical activity.
Week 0 (baseline) survey and Week 6 survey
Procceses of change
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to complete the Processes of Change questionnaire (Marcus et al., 1992) to assess the cognitive and behavioural strategies affecting their physical activity habits in the past week.
Week 0 (baseline) survey and Week 6 survey
Decisional balance
Time Frame: Week 0 (baseline) survey and Week 6 survey
Participants will be asked to complete the Decisional Balance questionnaire (Nigg et al., 1998) to assess their perceived pros/benefits and cons/barriers for engaging in physical activity.
Week 0 (baseline) survey and Week 6 survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Collaborators

Canadian Institutes of Health Research (CIHR)
Canadian Cancer Society (CCS)

Investigators

  • Principal Investigator: Jennifer Brunet, PhD, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156827

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants' data will be anonymized using a study identification number (i.e., Participant ID number) that will be stored using a protected file separated from the research data. This file will be stored on a secured Microsoft OneDrive server at the University of Ottawa where only the Provincial Applicant, Dr. Brunet, and study staff/volunteers supervised by Dr. Brunet will have access to the file/research data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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