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

Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Adult Acute Myeloid Leukemia; 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(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Untreated Adult Acute Myeloid Leukemia; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Intervention / Treatment: Procedure: quality-of-life assessment; Other: counseling intervention; Behavioral: exercise intervention; Other: educational intervention; Procedure: standard follow-up care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heidi Klepin, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 5, 2015
• Study Completion (Actual): February 5, 2017

Study Registration Dates

• First Submitted: January 20, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: IRB00019467; NCI-2012-00003 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 97711 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No