Leukemia
Conditions
Keywords
recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
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.
Interventions
BEHAVIORALexercise intervention
participation in physical activity intervention program weeks 2 through 5
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (AML) by WHO criteria * Planning to undergo induction or reinduction chemotherapy * Inpatient status at Wake Forest University Baptist Medical Center * Must not require intensive care unit support PATIENT CHARACTERISTICS: * Able to understand English * Medical eligibility confirmed with Leukemia Service Attending * Ambulatory or able to walk with a cane * No hemodynamic instability * No acute thrombosis within the past 7 days * No active ischemia within the past 7 days * No uncontrolled pain * Must have \< 3 incorrect responses on the Pfeiffer Mental Status Exam PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Record barriers to completion of the physical activity program | week 13 |
| 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 |
| Number and frequency of reported barriers to eligibility and enrollment | day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life as measured with the Distress Thermometer | week 13 |
| Physical function as measured by the Short Physical Performance Battery (SPPB) | week 13 |
Countries
United States
Outcome results
None listed