Implementing Exercise Into Clinical Practice in Breast Cancer Care
NCT ID: NCT04109274
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
85 participants
INTERVENTIONAL
2019-10-03
2024-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
One in eight women will develop breast cancer in their lifetime. With improved screening and treatment techniques, more women are surviving breast cancer. However, women live with physical and emotional side effects secondary to treatment for years after cancer treatments have ended. Exercise can help to manage these side effects, however, less than 30% of this population takes part in regular exercise. The objective of this trial is to determine the feasibility and effectiveness of a novel exercise and education program for women with breast cancer during chemotherapy.
METHODS:
Participants in this study include women with a diagnosis of stage 1 - 3 breast cancer undergoing chemotherapy. Women will be divided into three groups. The first group will include 8 sessions of exercise and self-management education during their chemotherapy treatment. The second group will receive self-management education only, and the third group will receive usual care. Outcomes will be compared between groups at baseline, post-intervention, and at 6- and 12- month follow up. Outcomes to be assessed include exercise level, functional mobility, muscle strength, quality of life, health status, and use of health care services.
EXPECTED OUTCOMES:
Women with breast cancer are among the least active segment of the Canadian population. It is well known that inactivity can lead to physical and psychological side effects, cancer recurrence, and an increase in comorbid conditions. This proposed project addresses a long-standing need to help women with breast cancer become and stay more active by implementing a novel exercise and education program.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
NCT03087461
Can Exercise Training Reduce the Frequency and Severity of Hot Flushes Associated With Breast Cancer Treatment?
NCT03286257
Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
NCT03679559
NEXT (Nutrition and EXercise During Adjuvant Treatment) Study
NCT01806181
Physical Activity or Usual Care in Preventing Weight Gain in Women With Stage I or Stage II Breast Cancer Undergoing Chemotherapy
NCT00509626
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Institution-Based Exercise and Self-Management (EXSM)
Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
Exercise
Exercise component: Aerobic exercise, using recumbent bikes, delivered within the cancer institution. Participants will take part in up to 30-minutes of moderate intensity (50-70% HRmax or 4-6/10 on Rate of Perceived Exertion scale)6 exercise for eight sessions during chemotherapy. An exercise specialist with experience in cancer rehabilitation will supervise the exercise component.
Self-Management
Eight SM modules will be delivered to participants. They will be viewed on an iPad prior to or after the exercise component. The goal of these modules is to aid participants in developing physical activity goals and action plans to continue with between sessions, with an overarching goal of helping them reach exercise guidelines for cancer survivors and the Canadian Physical Activity Guidelines
Booster Sessions
Four booster sessions will be provided to participants in this group. These will occur at 2, 4, 6, and 8 months post intervention completion. An assessor trained in behavioural counselling will provide booster sessions by phone and will discuss the individuals physical and emotional condition, current exercise level, accomplishment of previously set goals and action plans, and perceived barriers to participation in exercise. The assessor will use facilitation strategies to aid participants in devising strategies to overcome barriers and set realistic goals and action plans.
Institution-Based Self-management only (SM)
Eight SM sessions for safe and effective exercise strategies will be provided to this group (described above). Four booster sessions will be provided to this group.
Self-Management
Eight SM modules will be delivered to participants. They will be viewed on an iPad prior to or after the exercise component. The goal of these modules is to aid participants in developing physical activity goals and action plans to continue with between sessions, with an overarching goal of helping them reach exercise guidelines for cancer survivors and the Canadian Physical Activity Guidelines
Booster Sessions
Four booster sessions will be provided to participants in this group. These will occur at 2, 4, 6, and 8 months post intervention completion. An assessor trained in behavioural counselling will provide booster sessions by phone and will discuss the individuals physical and emotional condition, current exercise level, accomplishment of previously set goals and action plans, and perceived barriers to participation in exercise. The assessor will use facilitation strategies to aid participants in devising strategies to overcome barriers and set realistic goals and action plans.
Usual care
Participants in this group will receive care as normally provided by their treating oncologist. This can be heterogeneous between different physicians and centres, but usually includes oncologists encouraging their patients to 'stay active'
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise
Exercise component: Aerobic exercise, using recumbent bikes, delivered within the cancer institution. Participants will take part in up to 30-minutes of moderate intensity (50-70% HRmax or 4-6/10 on Rate of Perceived Exertion scale)6 exercise for eight sessions during chemotherapy. An exercise specialist with experience in cancer rehabilitation will supervise the exercise component.
Self-Management
Eight SM modules will be delivered to participants. They will be viewed on an iPad prior to or after the exercise component. The goal of these modules is to aid participants in developing physical activity goals and action plans to continue with between sessions, with an overarching goal of helping them reach exercise guidelines for cancer survivors and the Canadian Physical Activity Guidelines
Booster Sessions
Four booster sessions will be provided to participants in this group. These will occur at 2, 4, 6, and 8 months post intervention completion. An assessor trained in behavioural counselling will provide booster sessions by phone and will discuss the individuals physical and emotional condition, current exercise level, accomplishment of previously set goals and action plans, and perceived barriers to participation in exercise. The assessor will use facilitation strategies to aid participants in devising strategies to overcome barriers and set realistic goals and action plans.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* English-speaking women
* over 18 years of age
* currently undergoing adjuvant or neoadjuvant chemotherapy for Stage 1-3 breast cancer
* cleared by their oncologist to participate in moderate intensity aerobic exercise
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hamilton Health Sciences Corporation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Smith-Turchyn J, Mukherjee S, Richardson J, Ball E, Bordeleau L, Neil-Sztramko S, Levine O, Thabane L, Sathiyapalan A, Sabiston C. Evaluation of a novel strategy to implement exercise evidence into clinical practice in breast cancer care: protocol for the NEXT-BRCA randomised controlled trial. BMJ Open Sport Exerc Med. 2020 Oct 7;6(1):e000922. doi: 10.1136/bmjsem-2020-000922. eCollection 2020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEXT-BRCA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.