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Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00554489
  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
Procedure: exercise intervention
Procedure: management of therapy complications
Procedure: medical chart review
Procedure: quality-of-life assessment
Procedure: questionnaire administration

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care
Official Title: A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554489

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
Sponsors and Collaborators
Wake Forest University
Investigators
Study Chair: Suzanne C. Danhauer, PhD Wake Forest University
Investigator: Heidi D. Klepin, MD Wake Forest University
Investigator: Shannon Mihalko, PhD Wake Forest University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000573938, CCCWFU-98107, IRB00003355
Study First Received: November 6, 2007
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00554489  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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)

Study placed in the following topic categories:
Leukemia
Acute myelogenous leukemia
Acute myeloid leukemia, adult
Leukemia, Myeloid
Congenital Abnormalities
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009