Exercise During Chemotherapy in Older Women With Stage I-III Breast Cancer
NCT ID: NCT05025059
Last Updated: 2025-09-05
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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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2020-12-03
2026-12-31
Brief Summary
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Detailed Description
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I. Determine the feasibility of implementing a home-based exercise intervention in older adults receiving chemotherapy for early-stage breast cancer.
SECONDARY OBJECTIVES:
I. Describe and determine the incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3-5 toxicities overall and in three risk subgroups ("low-risk," "mid-risk" and "high-risk") determined by the Cancer and Aging Research Group-Breast Cancer (CARG-BC) tool.
II. Evaluate the accuracy of the CARG-BC tool in predicting the incidence of CTCAE grade 3-5 toxicities.
III. Determine the incidence of dose-reductions, dose-delays, treatment discontinuation and reduced-dose intensity (RDI; defined as \< 85% of total dose) overall and in the three risk subgroups.
IV. Determine the incidence of hospitalizations overall and in the three risk subgroups.
V. To examine the effect of the intervention on quality of life overall and in the three risk subgroups, as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
VI. To examine the effect of the intervention on function overall and in the three risk subgroups.
VII. To examine the effects of the intervention on patient expectation and self-efficacy, as assessed by Outcomes Expectations for Exercise (OEE) and Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM) respectively.
OUTLINE:
Patients participate in one-on-one coaching sessions with a health coach once a week (QW) to discuss the content offered in the program, and challenges they are currently facing in achieving their exercise goals. Patients receive a copy of the Walk with Ease Program (WWE) workbook, wear a fitness tracker and are encouraged to achieve 150 minutes of walking per week during chemotherapy and up to 1 month after chemotherapy. Patients also participate in the Growing Stronger Strength Training Program and receive instruction manuals. They perform the initial 2 exercises 2 days per week for 4 weeks, and subsequent 2 exercises 2 days per week for the remainder of the chemotherapy course. Patients maintain exercise logs and complete questionnaires over 30-45 minutes at baseline, end of chemotherapy and at 1 month after chemotherapy.
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 (coaching, exercise, questionnaire)
Patients participate in one-on-one coaching sessions with a health coach QW to discuss the content offered in the program, and challenges they are currently facing in achieving their exercise goals. Patients receive a copy of the WWE workbook, wear a fitness tracker and are encouraged to achieve 150 minutes of walking per week during chemotherapy and up to 1 month after chemotherapy. Patients also participate in the Growing Stronger Strength Training Program and receive instruction manuals. They perform the initial 2 exercises 2 days per week for 4 weeks, and subsequent 2 exercises 2 days per week for the remainder of the chemotherapy course. Patients maintain exercise logs and complete questionnaires over 30-45 minutes at baseline, end of chemotherapy and at 1 month after chemotherapy.
Discussion
Participate in coaching sessions
Exercise Intervention
Perform walking exercise
Exercise Intervention
Perform strength exercises
Informational Intervention
Receive WWE workbook and Growing Stronger Strength Training Program instruction manual
Informational Intervention
Maintain exercise log
Medical Device Usage and Evaluation
Wear fitness tracker
Quality-of-Life Assessment
Complete questionnaires
Questionnaire Administration
Complete questionnaires
Interventions
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Discussion
Participate in coaching sessions
Exercise Intervention
Perform walking exercise
Exercise Intervention
Perform strength exercises
Informational Intervention
Receive WWE workbook and Growing Stronger Strength Training Program instruction manual
Informational Intervention
Maintain exercise log
Medical Device Usage and Evaluation
Wear fitness tracker
Quality-of-Life Assessment
Complete questionnaires
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
* Scheduled to begin adjuvant or neoadjuvant chemotherapy regimen either as standard-of-care or on study
* English or Spanish speaking
* Able to provide written, informed consent
* Patient-assessed ability to walk and engage in moderate physical activity
* Willing and able to meet all study requirements
Exclusion Criteria
65 Years
FEMALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Meghan Karuturi
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-08757
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0638
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0638
Identifier Type: -
Identifier Source: org_study_id
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