Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy

Conditions
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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

Intervention / Treatment
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* Procedure: quality-of-life assessment
* Other: counseling intervention
* Behavioral: exercise intervention
* Other: educational intervention
* Procedure: standard follow-up care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (physical activity)<br>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. | Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: counseling intervention<br>* Receive lifestyle-related counseling<br>* Other names: counseling and communications studies;Behavioral: exercise intervention<br>* Undergo physical activity intervention<br>Other: educational intervention<br>* Receive educational materials<br>* Other names: intervention, educational;|
| Active Comparator: Arm II (usual care)<br>Patients undergo usual care for 4 weeks. | Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Procedure: standard follow-up care<br>* Undergo usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, in terms of participation rates and barriers to recruitment and retention | 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. | Approximately 4 weeks | 
| Magnitude and trajectory of changes in objective physical function | Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data. | Approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |