Trial Title:
Physical Activity for Adults in the Ontario Breast Screening Program
NCT ID:
NCT06405568
Condition:
Breast Cancer Female
Physical Inactivity
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Healthcare providers
Physical activity
Breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Double (Participant, Investigator)
Masking description:
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.
Intervention:
Intervention type:
Behavioral
Intervention name:
Physical activity intervention
Description:
Participants will receive a copy of physical activity (PA) recommendations plus a PA
motivation package - namely three 20-minute 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).
Arm group label:
Physical activity recommendations plus motivation package (Intervention Arm)
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).
Criteria for 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)
Gender:
Female
Minimum age:
30 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
June 1, 2024
Completion date:
June 1, 2025
Lead sponsor:
Agency:
University of Ottawa
Agency class:
Other
Collaborator:
Agency:
Canadian Institutes of Health Research (CIHR)
Agency class:
Other
Collaborator:
Agency:
Canadian Cancer Society (CCS)
Agency class:
Other
Source:
University of Ottawa
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06405568
http://www.pahealthpromolab.com
