Clinical trial NCT00554489: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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)
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-11-07
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: day 1
measure: Percentage of eligible patients recruited into the study
timeFrame: day 1
measure: Number and frequency of reported barriers to eligibility and enrollment
timeFrame: day 1
measure: Percentage of study participants who successfully completed the physical and the psychosocial measures
timeFrame: week 13
measure: Record barriers to completion of the physical activity program
timeFrame: week 13
Secondary outcomes:
measure: Physical function as measured by the Short Physical Performance Battery (SPPB)
timeFrame: week 13
measure: Quality of Life as measured with the Distress Thermometer
timeFrame: week 13
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne C. Danhauer, PhD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: Heidi D. Klepin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Shannon Mihalko, PhD
role: PRINCIPAL_INVESTIGATOR
References: