AzTrials
AzTrials

Breast Cancer FemaleNCT06405568

Physical Activity for Adults in the Ontario Breast Screening Program

A study testing Physical activity intervention in people with Breast Cancer Female and Physical Inactivity, run by University of Ottawa.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 69 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer Female, Physical Inactivity
What is being tested?
Physical activity intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 1 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 69 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Julia Hussien, PhD contact

613-562-5800 ext. 7300

jhussien@uottawa.ca

Jennifer Brunet, PhD contact

613-562-5800 ext. 3068

jennifer.brunet@uottawa.ca

About this study

Official title: 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.

Read the 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).

Being tested
Physical activity intervention
Keywords
Healthcare providers, Physical activity, Breast cancer
Medical subject headings
Sedentary Behavior, Motor Activity, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity interventionBehavioural

    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).

Study groups in NCT06405568
Study groupRoleWhat they receive
Physical activity recommendations plus motivation package (Intervention Arm)ExperimentalParticipants 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.
Receives: Behavioral: Physical activity intervention
Standard care and physical activity recommendations (Control Arm)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 0 (baseline) survey and Week 6 survey

  2. 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.

    Measured: Week 0 (baseline) survey and Week 6 survey

Secondary outcomes (2)

  1. 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).

    Measured: Week 0 (baseline) survey and Week 6 survey

  2. 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.

    Measured: Week 0 (baseline) survey and Week 6 survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06405568
Sponsor's protocol ID
156827
Status last verified
Jul 2026
First submitted
12 Apr 2024
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nigg CR, Rossi JS, Norman GJ, Benisovich SV. Structure of decisional balance for exercise adoption. Annals of Behavioral Medicine. 1998;20:S211.

  • Wilson PM, Rodgers WM, Loitz CC, Scime G. "It's Who I Am… Really!'The importance of integrated regulation in exercise contexts 1. Journal of Applied Biobehavioral Research. 2006 Apr;11(2):79-104. doi: 10.1111/j.1751-9861.2006.tb00021.x.

  • Wilson PM, Rogers WT, Rodgers WM, Wild TC. The psychological need satisfaction in exercise scale. Journal of Sport and Exercise Psychology. 2006 Sep 1;28(3):231-51. doi: 10.1123/jsep.28.3.231

  • Mackinnon A, Jorm AF, Christensen H, Korten AE, Jacomb PA, Rodgers B. A short form of the Positive and Negative Affect Schedule: Evaluation of factorial validity and invariance across demographic variables in a community sample. Personality and Individual differences. 1999 Sep;27(3):405-16. doi: 10.1016/S0191-8869(98)00251-7

  • Ligibel JA, Basen-Engquist K, Bea JW. Weight Management and Physical Activity for Breast Cancer Prevention and Control. Am Soc Clin Oncol Educ Book. 2019 Jan;39:e22-e33. doi: 10.1200/EDBK_237423. Epub 2019 May 17.

    PubMed 31099634

  • Statistics Canada. Table 13-10-0096-13 Physical activity, self reported, adult, by age group [Data set]. Statistics Canada. 2020 Nov. https://doi.org/https://doi.org/10.25318/1310009601-eng

  • Kehm RD, Genkinger JM, MacInnis RJ, John EM, Phillips KA, Dite GS, Milne RL, Zeinomar N, Liao Y, Knight JA, Southey MC, Chung WK, Giles GG, McLachlan SA, Whitaker KD, Friedlander M, Weideman PC, Glendon G, Nesci S, Investigators K, Andrulis IL, Buys SS, Daly MB, Hopper JL, Terry MB. Recreational Physical Activity Is Associated with Reduced Breast Cancer Risk in Adult Women at High Risk for Breast Cancer: A Cohort Study of Women Selected for Familial and Genetic Risk. Cancer Res. 2020 Jan 1;80(1):116-125. doi: 10.1158/0008-5472.CAN-19-1847. Epub 2019 Oct 2.

    PubMed 31578201

  • Bernstein L. Exercise and breast cancer prevention. Curr Oncol Rep. 2009 Nov;11(6):490-6. doi: 10.1007/s11912-009-0066-7.

    PubMed 19840527

  • Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.

    PubMed 23512568

  • Marcus BH, Rossi JS, Selby VC, Niaura RS, Abrams DB. The stages and processes of exercise adoption and maintenance in a worksite sample. Health Psychol. 1992;11(6):386-95. doi: 10.1037//0278-6133.11.6.386.

    PubMed 1286658

  • Golaszewski NM, Bartholomew JB. The Development of the Physical Activity and Social Support Scale. J Sport Exerc Psychol. 2019 Aug 1;41(4):215-229. doi: 10.1123/jsep.2018-0234.

    PubMed 31461243

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PubMed 3397865

  • McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004.

    PubMed 8277801

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity intervention in people with Breast Cancer Female and Physical Inactivity, run by University of Ottawa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julia Hussien, PhD (613-562-5800 ext. 7300, jhussien@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (PA; aerobic) (time frame: Week 0 (baseline) survey and Week 6 survey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06405568, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in