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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-98107 | |||
| IRB00003355 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Physical activity sessions may help improve physical function, quality of life, and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.
PURPOSE: This clinical trial is studying how well physical activity works in improving quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo a baseline evaluation in week 1 focusing on basic demographics, health, physical function and quality-of-life assessments. These assessments include the Short Physical Performance Battery (SPPB); the Hand Grip Test of Muscular Strength; the Demographics and Physical Activity History; the Functional Assessment of Cancer Therapy (FACT-Leu); the Distress Thermometer; the Short-form Positive Affect Schedule (PANAS-SF); the Satisfaction with Life Scale (SWL); the FAST-23 Disability Measure; the Center for Epidemiologic Studies Depression Scale Short Form (CES-D); the Self-efficacy for Physical Activity Scale; the Intervention Feedback Form; and the Pre-Post Session Ratings. Some medical data may be obtained from the patient's medical record to assist in these assessments.
Beginning in weeks 2-5, patients undergo a 30-minute orientation to the exercise sessions that will be tailored to individual needs and abilities. Patients undergo a 30- to 45-minute group physical activity session twice a week, and a supervised individual session following the same format as the group session, once a week for 4 weeks. After completion of the physical activity intervention, patients complete an activities packet and repeat the physical function and quality of life assessments in weeks 5-6 and again upon readmission for consolidation therapy in weeks 9-13 .
After completion of study intervention, patients are followed for 4 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise intervention | Behavioral | participation in physical activity intervention program weeks 2 through 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adults 50 years of age or older admitted for induction or reinduction chemotherapy for acute myeloid leukemia (AML) who are eligible for the study | day 1 | |
| Percentage of eligible patients recruited into the study | day 1 | |
| Number and frequency of reported barriers to eligibility and enrollment | day 1 | |
| Percentage of study participants who successfully completed the physical and the psychosocial measures | week 13 | |
| Record barriers to completion of the physical activity program | week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function as measured by the Short Physical Performance Battery (SPPB) | week 13 | |
| Quality of Life as measured with the Distress Thermometer | week 13 |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne C. Danhauer, PhD | Wake Forest University Health Sciences | Study Chair |
| Heidi D. Klepin, MD | Wake Forest University Health Sciences | Principal Investigator |
| Shannon Mihalko, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D007951 | Leukemia, Myeloid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |