Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors
NCT ID: NCT04454086
Last Updated: 2024-04-02
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
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COMPLETED
NA
21 participants
INTERVENTIONAL
2019-03-06
2021-07-27
Brief Summary
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Detailed Description
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I. To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.
II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for producing meaningful improvements in select clinically-relevant anthropometric, fitness, functional, and patient-reported outcomes in BC survivors.
III. Provide the effect size estimates necessary to inform the design of a subsequent R01 application addressing a large scale, optimally powered, randomized controlled, community-based LWM comparative efficacy intervention trial targeting weight loss in BC survivors.
OUTLINE:
Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.
After completion of study, patients are followed up at 3 and 6 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (exercise program, counseling)
Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.
Aerobic Exercise
Undergo aerobic exercise
Exercise Counseling
Receive behavioral activity counseling
Nutritional Assessment
Receive nutritional counseling
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Resistance Training
Undergo resistance exercises
Interventions
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Aerobic Exercise
Undergo aerobic exercise
Exercise Counseling
Receive behavioral activity counseling
Nutritional Assessment
Receive nutritional counseling
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Resistance Training
Undergo resistance exercises
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Overweight/obese (body mass index \[BMI\] \> 25).
* Ability to understand and the willingness to sign a written informed consent.
* Willing and physically able to participate in physical activity.
* Obtain physician consent via primary care physician and/or treating oncologist.
Exclusion Criteria
* Contraindications to exercise.
* Diagnosis of cancer other than breast that is receiving active treatment.
* Currently receiving chemotherapy/radiation.
* Musculoskeletal/neurological disorder inhibiting them from safe exercise.
* Pregnant or nursing women.
* Unable to give informed consent.
30 Years
75 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Brian Focht
Principal Investigator
Principal Investigators
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Brian C Focht, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2019-00570
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-17122
Identifier Type: -
Identifier Source: org_study_id
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