Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
Primary Purpose
Leukemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise intervention
Sponsored by

About this trial
This is an interventional supportive care trial for Leukemia focused on measuring recurrent 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(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
Eligibility Criteria
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
Sites / Locations
- Wake Forest University Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
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
Percentage of eligible patients recruited into the study
Number and frequency of reported barriers to eligibility and enrollment
Percentage of study participants who successfully completed the physical and the psychosocial measures
Record barriers to completion of the physical activity program
Secondary Outcome Measures
Physical function as measured by the Short Physical Performance Battery (SPPB)
Quality of Life as measured with the Distress Thermometer
Full Information
NCT ID
NCT00554489
First Posted
November 6, 2007
Last Updated
August 14, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00554489
Brief Title
Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
Official Title
A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent 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(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Intervention Description
participation in physical activity intervention program weeks 2 through 5
Primary Outcome Measure Information:
Title
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
Time Frame
day 1
Title
Percentage of eligible patients recruited into the study
Time Frame
day 1
Title
Number and frequency of reported barriers to eligibility and enrollment
Time Frame
day 1
Title
Percentage of study participants who successfully completed the physical and the psychosocial measures
Time Frame
week 13
Title
Record barriers to completion of the physical activity program
Time Frame
week 13
Secondary Outcome Measure Information:
Title
Physical function as measured by the Short Physical Performance Battery (SPPB)
Time Frame
week 13
Title
Quality of Life as measured with the Distress Thermometer
Time Frame
week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne C. Danhauer, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heidi D. Klepin, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shannon Mihalko, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
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