Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-12
Brief Title:
Physical Activity for Adults in the Ontario Breast Screening Program
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Support for Physical Activity for Adults Registered in the Ontario Breast Screening Program A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 ones 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 inactivity 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 eg 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 httpscsepguidelinescaguidelinesadults-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 ie 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 ie 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 eg inadequate training lack of timeknowledge Research needs to focus on developing sustainable interventions that can be implemented broadly using distance-based approaches and available infrastructure eg 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 eg 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
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 eg inadequate training lack of timeknowledge Research needs to focus on developing sustainable interventions that can be implemented broadly using distance-based approaches and available infrastructure eg 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None