Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
- Conditions
- Leukemia
- Registration Number
- NCT00554489
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy.
Secondary
* To obtain preliminary data regarding the effectiveness of a physical activity intervention on physical function, quality of life, and treatment-related symptoms in these patients.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of eligible patients recruited into the study day 1 Percentage of study participants who successfully completed the physical and the psychosocial measures week 13 Number and frequency of reported barriers to eligibility and enrollment day 1 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 Record barriers to completion of the physical activity program week 13
- Secondary Outcome Measures
Name Time Method Physical function as measured by the Short Physical Performance Battery (SPPB) week 13 Quality of Life as measured with the Distress Thermometer week 13
Trial Locations
- Locations (1)
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States