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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014