An interventional study of Physical activity intervention in Breast Cancer Female and Physical Inactivity, sponsored by University of Ottawa. Not yet recruiting. Open to female participants aged 30 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University of Ottawa · Not applicable, Interventional, and Treatment
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.
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).
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of Ottawa is the lead sponsor of 125 studies on the registry; 34 are open to participants now.
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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
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 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.
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 (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: 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.
Time frame: Week 0 (baseline) survey and Week 6 survey
Quality of life (QoL)
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).
Time frame: Week 0 (baseline) survey and Week 6 survey
Body mass index (BMI)
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.
Time frame: Week 0 (baseline) survey and Week 6 survey
Behaviour change technique use
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.
Time frame: Week 0 (baseline) survey and Week 6 survey
Positive and negative affect
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).
Time frame: Week 0 (baseline) survey and Week 6 survey
Mental health state: Depression
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).
Time frame: Week 0 (baseline) survey and Week 6 survey
Mental healh state: Generalized anxiety
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).
Time frame: Week 0 (baseline) survey and Week 6 survey
Physical activity behavioural regulations
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.
Time frame: Week 0 (baseline) survey and Week 6 survey
Basic psychological needs satisfaction
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.
Time frame: Week 0 (baseline) survey and Week 6 survey
Social support
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.
Time frame: Week 0 (baseline) survey and Week 6 survey
Procceses of change
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.
Time frame: Week 0 (baseline) survey and Week 6 survey
Decisional balance
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.
Time frame: Week 0 (baseline) survey and Week 6 survey
No study locations are listed for this record.
Plan to share: No
Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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