Physical Activity for Adults in the Ontario Breast Screening Program

NCT06405568 — Not applicable, Not yet recruiting, 200 participants, University of Ottawa
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Support for Physical Activity for Adults Registered in the Ontario Breast Screening Program: A Randomized Controlled Trial

RegistryNCT06405568
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment200 (Estimated)
SponsorUniversity of Ottawa (Other); collaborators: Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
ConditionsBreast Cancer Female, Physical Inactivity
InterventionsPhysical activity intervention (Behavioral)
Datesstart 2026-08-01 (estimated), primary completion 2028-08-01 (estimated), completion 2028-08-01 (estimated), first posted 2024-05-08, last updated 2026-07-10

Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer Female All trials for Physical Inactivity All trials of Physical activity intervention

-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Physical activity recommendations plus motivation package (Intervention Arm)ExperimentalBehavioral: Physical activity interventionParticipants 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.
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.
  • 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).

+Outcome measures

Primary outcomes

  • Physical activity (PA; aerobic) [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.
  • Physical activity (PA; strength) [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.

Secondary outcomes

  • Quality of life (QoL) [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).
  • Body mass index (BMI) [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.

Other outcomes

  • Behaviour change technique use [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.
  • Positive and negative affect [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).
  • Mental health state: Depression [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).
  • Mental healh state: Generalized anxiety [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).
  • Physical activity behavioural regulations [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.
  • Basic psychological needs satisfaction [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.
  • Social support [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.
  • Procceses of change [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.
  • Decisional balance [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.

+Eligibility

Sex: Female, ages: 30 Years to 69 Years, accepts healthy volunteers

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)

+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. PMID 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. PMID 31578201
  • Bernstein L. Exercise and breast cancer prevention. Curr Oncol Rep. 2009 Nov;11(6):490-6. doi: 10.1007/s11912-009-0066-7. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 8277801
  • Friedenreich CM, Ryder-Burbidge C, McNeil J. Physical activity, obesity and sedentary behavior in cancer etiology: epidemiologic evidence and biologic mechanisms. Mol Oncol. 2021 Mar;15(3):790-800. doi: 10.1002/1878-0261.12772. Epub 2020 Aug 18. PMID 32741068
  • McTiernan A, Friedenreich CM, Katzmarzyk PT, Powell KE, Macko R, Buchner D, Pescatello LS, Bloodgood B, Tennant B, Vaux-Bjerke A, George SM, Troiano RP, Piercy KL; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity in Cancer Prevention and Survival: A Systematic Review. Med Sci Sports Exerc. 2019 Jun;51(6):1252-1261. doi: 10.1249/MSS.0000000000001937. PMID 31095082
  • McTiernan A, Schwartz RS, Potter J, Bowen D. Exercise clinical trials in cancer prevention research: a call to action. Cancer Epidemiol Biomarkers Prev. 1999 Mar;8(3):201-7. PMID 10090297
  • Patel AV, Friedenreich CM, Moore SC, Hayes SC, Silver JK, Campbell KL, Winters-Stone K, Gerber LH, George SM, Fulton JE, Denlinger C, Morris GS, Hue T, Schmitz KH, Matthews CE. American College of Sports Medicine Roundtable Report on Physical Activity, Sedentary Behavior, and Cancer Prevention and Control. Med Sci Sports Exerc. 2019 Nov;51(11):2391-2402. doi: 10.1249/MSS.0000000000002117. PMID 31626056
  • Hebert ET, Caughy MO, Shuval K. Primary care providers' perceptions of physical activity counselling in a clinical setting: a systematic review. Br J Sports Med. 2012 Jul;46(9):625-31. doi: 10.1136/bjsports-2011-090734. PMID 22711796
  • Haines TP, Sinnamon P, Wetzig NG, Lehman M, Walpole E, Pratt T, Smith A. Multimodal exercise improves quality of life of women being treated for breast cancer, but at what cost? Randomized trial with economic evaluation. Breast Cancer Res Treat. 2010 Nov;124(1):163-75. doi: 10.1007/s10549-010-1126-2. Epub 2010 Aug 24. PMID 20734132
  • Ormel HL, van der Schoot GGF, Sluiter WJ, Jalving M, Gietema JA, Walenkamp AME. Predictors of adherence to exercise interventions during and after cancer treatment: A systematic review. Psychooncology. 2018 Mar;27(3):713-724. doi: 10.1002/pon.4612. Epub 2018 Jan 26. PMID 29247584
  • Sevick MA, Dunn AL, Morrow MS, Marcus BH, Chen GJ, Blair SN. Cost-effectiveness of lifestyle and structured exercise interventions in sedentary adults: results of project ACTIVE. Am J Prev Med. 2000 Jul;19(1):1-8. doi: 10.1016/s0749-3797(00)00154-9. PMID 10865157
  • Brunet J, Wurz A, Nader PA, Belanger M. A systematic review summarizing the effect of health care provider-delivered physical activity interventions on physical activity behaviour in cancer survivors. Patient Educ Couns. 2020 Jul;103(7):1287-1301. doi: 10.1016/j.pec.2020.02.002. Epub 2020 Feb 8. PMID 32067858
  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. PMID 4053261

+Investigators