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

Wake Forest University (WFU)

Status: Completed

Conditions: Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Untreated 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(8;21)(q22;q22); Recurrent Adult Acute Myeloid Leukemia; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With Del(5q)

Treatments: Other: counseling intervention; Procedure: standard follow-up care; Other: educational intervention; Behavioral: exercise intervention; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01519596

IRB00019467

CCCWFU 97711 (Other Identifier)

NCI-2012-00003 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Arm I (physical activity)

Experimental group

Description:

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.

Treatment:

Procedure: quality-of-life assessment

Behavioral: exercise intervention

Other: educational intervention

Other: counseling intervention

Arm II (usual care)

Active Comparator group

Description:

Patients undergo usual care for 4 weeks.

Treatment:

Procedure: quality-of-life assessment

Procedure: standard follow-up care