- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05025059
Exercise During Chemotherapy in Older Women With Stage I-III Breast Cancer
The EXCitE Study: Exercise During Chemotherapy in Older Women With Early-Stage Breast Cancer
Study Overview
Status
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
Detailed Description
PRIMARY OBJECTIVE:
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 65 years or older, female
- 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:
- The presence of significant medical conditions that in the physician's judgement preclude participation in the exercise intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Complete questionnaires
Participate in coaching sessions
Other Names:
Perform walking exercise
Perform strength exercises
Receive WWE workbook and Growing Stronger Strength Training Program instruction manual
Maintain exercise log
Wear fitness tracker
Complete questionnaires
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: Up to 1 month after chemotherapy
|
Will be calculated as the ratios of (a) the average number of exercise sessions completed weekly to total number of weekly targeted sessions during the period of chemotherapy (goal = 5 for walking sessions and 2 for upper-extremity exercises wearable.
The mean adherence will be calculated for each patient.
|
Up to 1 month after chemotherapy
|
Compliance
Time Frame: Up to 1 month after chemotherapy
|
Compliance will be calculated as the ratio of the average total number of valid days (>= 10 hours /day of use) to the total number of weekly targeted days (goal = 5).
The mean compliance will be calculated for each patient.
|
Up to 1 month after chemotherapy
|
Retention
Time Frame: Up to 1 month after chemotherapy
|
Will be assessed as the proportion of patients who enrolled in the study who complete all questionnaires and assessments at all time points.
|
Up to 1 month after chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs)
Time Frame: Up to 1 month after chemotherapy
|
Chemotherapy toxicity will be measured per Common Terminology Criteria for Adverse Events version 5.0.
All AEs (grade 1-5) will be captured at each follow-up visit during chemotherapy.
|
Up to 1 month after chemotherapy
|
Geriatric assessment
Time Frame: Baseline up to 1 month after chemotherapy
|
The Wilcoxon signed rank test will be used to assess the changes of geriatric assessment measures.
|
Baseline up to 1 month after chemotherapy
|
Short Physical Performance Battery (SPPB)
Time Frame: Baseline up to 1 month after chemotherapy
|
The Wilcoxon signed rank test will be used to assess the changes physical performance (SBBP).
|
Baseline up to 1 month after chemotherapy
|
Quality of life questionnaires
Time Frame: Baseline up to 1 month after chemotherapy
|
Assessed using Functional Assessment of Cancer Therapy-Breast and Functional Assessment of Chronic Illness Therapy-Fatigue.
The Wilcoxon signed rank test will be used to assess the changes of quality of life measures.
|
Baseline up to 1 month after chemotherapy
|
Outcome Expectations for Exercise (OEE) Scale Questionnaires
Time Frame: Baseline up to 1 month after chemotherapy
|
The Wilcoxon signed rank test will be used to assess the changes of expectations for exercise (OEE) within patient from baseline to each follow-up time point.
Scale 1 (Strongly Disagree) to 5 (Strongly Agree)
|
Baseline up to 1 month after chemotherapy
|
Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM) questionnaires
Time Frame: Baseline up to 1 month after chemotherapy
|
The Wilcoxon signed rank test will be used to assess the changes self-efficacy for fatigue (PSEFSM) within patient from baseline to each follow-up time point.
PSEFSM 35-36 is a 6-item scale that uses a 10-point response option ranging from "not at all confident" to "total confident.
|
Baseline up to 1 month after chemotherapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meghan Karuturi, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0638 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-08757 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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