Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00554489
First received: November 6, 2007
Last updated: July 12, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

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 [ 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    Behavioral: exercise intervention
    participation in physical activity intervention program weeks 2 through 5
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
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
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 April 23, 2014