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

Overview

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 Title of Study: “Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 5, 2015

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

  • Procedure: quality-of-life assessment
    • Ancillary studies
  • Other: counseling intervention
    • Receive lifestyle-related counseling
  • Behavioral: exercise intervention
    • Undergo physical activity intervention
  • Other: educational intervention
    • Receive educational materials
  • Procedure: standard follow-up care
    • Undergo usual care

Arms, Groups and Cohorts

  • Experimental: Arm I (physical activity)
    • 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.
  • Active Comparator: Arm II (usual care)
    • Patients undergo usual care for 4 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility, in terms of participation rates and barriers to recruitment and retention
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength
    • Time Frame: Approximately 4 weeks
  • Self-reported quality of life
    • Time Frame: Approximately 24 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Heidi Klepin, Principal Investigator, Wake Forest University Health Sciences

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