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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08757 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0638 | Other Identifier | M D Anderson Cancer Center |
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This clinical trial evaluates the feasibility of exercise during chemotherapy in older women with stage I-III breast cancer. Previous studies have reported that exercise may reduce the chemotherapy-toxicity risk. This trial may help researchers learn if engaging in a physical activity program is feasible in patients receiving chemotherapy for breast cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (coaching, exercise, questionnaire) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discussion | Procedure | Participate in coaching sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghan Karuturi | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Exercise Intervention | Other | Perform walking exercise |
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| Exercise Intervention | Other | Perform strength exercises |
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| Informational Intervention | Other | Receive WWE workbook and Growing Stronger Strength Training Program instruction manual |
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| Informational Intervention | Other | Maintain exercise log |
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| Medical Device Usage and Evaluation | Other | Wear fitness tracker |
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| Quality-of-Life Assessment | Other | Complete questionnaires |
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| Questionnaire Administration | Other | Complete questionnaires |
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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) | 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 | 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 | 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 | 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 |