Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
NCT ID: NCT04106609
Last Updated: 2024-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
251 participants
INTERVENTIONAL
2019-08-23
2021-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise Group
Patients will complete a 60-minute exercise session once per week for 12 weeks. The exercise sessions will be individualized to the patient's needs and fitness level by a trainer. A patient will work with the same trainer throughout the study, who will plan the patient's individualized exercise regimen, and who will provide one-on-one supervision for the duration of each 60-minute session. Each 60-minute session will include cardiovascular, strength, and flexibility training. The intensity level for the aerobic exercise ranges from 30-45% of the individual's predicted VO2max, controlled by heart monitors and lasting 30 min. Strength training will involve a full body workout, with emphasis on all major muscle groups and employing machines, free weights, and resistance tubing. Patients will complete 3 sets of 10 repetitions for each strength exercise. Flexibility training will involve static stretching of all major muscle groups for 15-20 seconds at the completion of each workout.
Supervised, individualized exercise oncology program
The study intervention is a supervised, individualized exercise oncology program described in previous literature2,3,12 and provided by Maple Tree Cancer Alliance, a non-profit organization providing exercise training to individuals with cancer (https://www.mapletreecanceralliance.org/). This organization was founded in 2011 and currently operates in 9 hospitals serving Ohio and Pennsylvania, offering free exercise programs and nutritional guidance to approximately 500 patients annually to help relieve side effects related to cancer treatment.
Control Group
The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Current standard of care
Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Interventions
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Supervised, individualized exercise oncology program
The study intervention is a supervised, individualized exercise oncology program described in previous literature2,3,12 and provided by Maple Tree Cancer Alliance, a non-profit organization providing exercise training to individuals with cancer (https://www.mapletreecanceralliance.org/). This organization was founded in 2011 and currently operates in 9 hospitals serving Ohio and Pennsylvania, offering free exercise programs and nutritional guidance to approximately 500 patients annually to help relieve side effects related to cancer treatment.
Current standard of care
Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Eligibility Criteria
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Inclusion Criteria
* Initial stage 0, 1 or 2 breast cancer diagnosis within the past 12 weeks determined from electronic medical record
* Age 30-80; determined from electronic medical record
* Physician clearance to participate in exercise
Exclusion Criteria
* Currently pregnant or planning to become pregnant
* Non-English speaking
* Unable to make own medical decisions and/or to follow verbal instructions
30 Years
80 Years
FEMALE
No
Sponsors
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Karen Wonders
OTHER
Responsible Party
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Karen Wonders
Executive Director, Maple Tree Cancer Alliance
Principal Investigators
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Karen Wonders, PhD, FACSM
Role: PRINCIPAL_INVESTIGATOR
Maple Tree Cancer Alliance
Locations
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Maple Tree Cancer Alliance
Dayton, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Maple Tree Exercise
Identifier Type: -
Identifier Source: org_study_id
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