Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia

RATIONALE: Physical activity sessions may help improve physical function, quality of life, and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.

PURPOSE: This clinical trial is studying how well physical activity works in improving quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Behavioral: exercise intervention

Detailed Description

OBJECTIVES:

Primary

• To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy.

Secondary

• To obtain preliminary data regarding the effectiveness of a physical activity intervention on physical function, quality of life, and treatment-related symptoms in these patients.

OUTLINE: Patients undergo a baseline evaluation in week 1 focusing on basic demographics, health, physical function and quality-of-life assessments. These assessments include the Short Physical Performance Battery (SPPB); the Hand Grip Test of Muscular Strength; the Demographics and Physical Activity History; the Functional Assessment of Cancer Therapy (FACT-Leu); the Distress Thermometer; the Short-form Positive Affect Schedule (PANAS-SF); the Satisfaction with Life Scale (SWL); the FAST-23 Disability Measure; the Center for Epidemiologic Studies Depression Scale Short Form (CES-D); the Self-efficacy for Physical Activity Scale; the Intervention Feedback Form; and the Pre-Post Session Ratings. Some medical data may be obtained from the patient's medical record to assist in these assessments.

Beginning in weeks 2-5, patients undergo a 30-minute orientation to the exercise sessions that will be tailored to individual needs and abilities. Patients undergo a 30- to 45-minute group physical activity session twice a week, and a supervised individual session following the same format as the group session, once a week for 4 weeks. After completion of the physical activity intervention, patients complete an activities packet and repeat the physical function and quality of life assessments in weeks 5-6 and again upon readmission for consolidation therapy in weeks 9-13 .

After completion of study intervention, patients are followed for 4 months.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-1096
      • Wake Forest University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed acute myeloid leukemia (AML) by WHO criteria
• Planning to undergo induction or reinduction chemotherapy
• Inpatient status at Wake Forest University Baptist Medical Center
• Must not require intensive care unit support

PATIENT CHARACTERISTICS:

• Able to understand English
• Medical eligibility confirmed with Leukemia Service Attending
• Ambulatory or able to walk with a cane
• No hemodynamic instability
• No acute thrombosis within the past 7 days
• No active ischemia within the past 7 days
• No uncontrolled pain
• Must have < 3 incorrect responses on the Pfeiffer Mental Status Exam

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of adults 50 years of age or older admitted for induction or reinduction chemotherapy for acute myeloid leukemia (AML) who are eligible for the study	day 1
Percentage of eligible patients recruited into the study	day 1
Number and frequency of reported barriers to eligibility and enrollment	day 1
Percentage of study participants who successfully completed the physical and the psychosocial measures	week 13
Record barriers to completion of the physical activity program	week 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Physical function as measured by the Short Physical Performance Battery (SPPB)	week 13
Quality of Life as measured with the Distress Thermometer	week 13

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heidi D. Klepin, MD, Wake Forest University Health Sciences; Principal Investigator: Shannon Mihalko, PhD, Wake Forest University Health Sciences; Study Chair: Suzanne C. Danhauer, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: November 6, 2007
• First Submitted That Met QC Criteria: November 6, 2007
• First Posted (Estimate): November 7, 2007

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; 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
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: CDR0000573938; CCCWFU-98107; IRB00003355

Drug and device information, study documents

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