Clinical trial NCT06405568: Physical Activity for Adults in the Ontario Breast Screening Program
Official title: Support for Physical Activity for Adults Registered in the Ontario Breast Screening Program: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Physical Inactivity
Keywords: Healthcare providers
Physical activity
Breast cancer
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canadian Cancer Society (CCS)
First posted: 2024-05-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Considerable research (\>500 studies) has examined the association between physical (in)activity and cancer incidence. 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). 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). 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. 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. 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Physical activity (PA; aerobic)
timeFrame: Week 0 (baseline) survey and Week 6 survey
measure: Physical activity (PA; strength)
timeFrame: Week 0 (baseline) survey and Week 6 survey
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: Week 0 (baseline) survey and Week 6 survey
measure: Body Mass Index (BMI)
timeFrame: Week 0 (baseline) survey and Week 6 survey
Other outcomes:
Locations:
Study officials:
affiliation: University of Ottawa
name: Jennifer Brunet, PhD
role: PRINCIPAL_INVESTIGATOR
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