Physical Activity for Adults in the Ontario Breast Screening Program

NCT06405568 | Not Yet Recruiting

• 1 other identifier: 156827
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer Female; Physical Inactivity

Keywords

Healthcare providers; Physical activity; Breast cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 0 (baseline) survey and Week 6 survey

• Physical activity (PA; strength)

  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 Outcomes (2)

• Quality of life (QoL)

  Week 0 (baseline) survey and Week 6 survey

• Body mass index (BMI)

  Week 0 (baseline) survey and Week 6 survey

Other Outcomes (9)

• Behaviour change technique use

  Week 0 (baseline) survey and Week 6 survey

• Positive and negative affect

  Week 0 (baseline) survey and Week 6 survey

• Mental health state: Depression

  Week 0 (baseline) survey and Week 6 survey

Study Arms (2)

Physical activity recommendations plus motivation package (Intervention Arm)

EXPERIMENTAL

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

Standard care and physical activity recommendations (Control Arm)

NO INTERVENTION

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.

Interventions

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).

Physical activity recommendations plus motivation package (Intervention Arm)

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Ottawa: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Cancer Society (CCS): collaborator

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Related Links

• Physical Activity and Health Promotion Laboratory Official Website

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Breast Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Brunet, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Hussien, PhD

CONTACT

613-562-5800; jhussien@uottawa.ca

Jennifer Brunet, PhD

CONTACT

613-562-5800; jennifer.brunet@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomization will be concealed to the investigators throughout the trial; the investigators will not take part in the assessments or intervention delivery. The randomization will be concealed to study staff and participants until informed consent and baseline data are obtained. Study staff will be unblinded to group allocation upon randomization to enable delivery of the intervention arm and control arm corresponding materials, whereas the randomization will remain concealed to participants. To support blinding, all participants will be informed they are being enrolled in a study investigating ways to promote PA and will be kept blind to the fact that the intervention arm receives more materials than the control arm, and thus all (including participants allocated to the control arm) will receive materials (i.e., a copy of PA recommendations). Moreover, we do not anticipate participants to have contact with participants of the other arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: The proposed study is a parallel-arm randomized controlled trial. Individuals enrolled in the Ontario Breast Screening Program for High-Risk Screening will be invited by mail to contact research staff who will obtain informed consent. Individuals who self-report engaging in \>150 minutes of moderate-to-vigorous intensity physical activity (PA) each week or a condition that makes it unsuitable for participation in this study (e.g., hypertension) will be excluded. Participants will receive a copy of PA recommendations plus a PA motivation package (intervention arm), or just a copy of PA recommendations (control arm); the control arm will receive the PA motivation package after study completion. All participants will complete primary (PA) and secondary (quality of life, BMI) outcome measures at baseline (pre-randomization) and after six weeks online. All outcomes will be analyzed according to intention-to-treat principles according to their randomized allocation and performed using SPSS.

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share