Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), 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), Recurrent Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Conditions
Brief summary
This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML undergoing chemotherapy.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral intervention designed to improve physical function in older adults receiving chemotherapy for AML. II. To estimate the effect size of the physical activity intervention on change in an objective measure of physical function, SPPB (short physical performance battery). SECONDARY OBJECTIVES: I. To estimate the effects of the physical activity intervention on self-reported physical function, health-related quality of life, and symptoms (depression, distress, fatigue). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly. ARM II: Patients undergo usual care for 4 weeks. After completion of study treatment, patients are followed up every two weeks for two months and then monthly until week 24.
Interventions
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERcounseling intervention
Receive lifestyle-related counseling
BEHAVIORALexercise intervention
Undergo physical activity intervention
OTHEReducational intervention
Receive educational materials
PROCEDUREstandard follow-up care
Undergo usual care
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AML with pathologic confirmation by World Health Organization (WHO) criteria * Planned induction chemotherapy * Absence of active medical problems that preclude participation in exercise (including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability, uncontrolled pain) * Patient must be ambulatory or able to walk with a cane * Patients must have limited cognitive deficits (\< 3 incorrect responses on the Pfeiffer Mental Status Scale) * Adequate English skills to understand and complete questionnaires * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Presence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability) * Inability to ambulate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, in terms of participation rates and barriers to recruitment and retention | Approximately 4 weeks | Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions. |
| Magnitude and trajectory of changes in objective physical function | Approximately 4 weeks | Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data. |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength | Approximately 4 weeks |
| Self-reported quality of life | Approximately 24 weeks |
Countries
United States
Outcome results
None listed