Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

Study Overview
=================
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.

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

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Behavioral: exercise intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise intervention|participation in physical activity intervention program weeks 2 through 5|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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)