Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Leukemia |
Behavioral: exercise intervention |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia |
- 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 ] [ Designated as safety issue: No ]
- Percentage of eligible patients recruited into the study [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- Number and frequency of reported barriers to eligibility and enrollment [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- Percentage of study participants who successfully completed the physical and the psychosocial measures [ Time Frame: week 13 ] [ Designated as safety issue: No ]
- Record barriers to completion of the physical activity program [ Time Frame: week 13 ] [ Designated as safety issue: No ]
- Physical function as measured by the Short Physical Performance Battery (SPPB) [ Time Frame: week 13 ] [ Designated as safety issue: No ]
- Quality of Life as measured with the Distress Thermometer [ Time Frame: week 13 ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | July 2007 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
-
Behavioral: exercise intervention
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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Study Chair: | Suzanne C. Danhauer, PhD | Comprehensive Cancer Center of Wake Forest University |
| Principal Investigator: | Heidi D. Klepin, MD | Comprehensive Cancer Center of Wake Forest University |
| Principal Investigator: | Shannon Mihalko, PhD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00554489 History of Changes |
| Other Study ID Numbers: | CDR0000573938, CCCWFU-98107, IRB00003355 |
| Study First Received: | November 6, 2007 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
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) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013