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Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

This study is currently recruiting participants.
Verified November 2012 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01519596
First received: January 20, 2012
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML undergoing chemotherapy.


Condition Intervention
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
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)
Recurrent Adult Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
 Procedure: quality-of-life assessment
Other: counseling intervention
Behavioral: exercise intervention
Other: educational intervention
Procedure: standard follow-up care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Feasibility, in terms of participation rates and barriers to recruitment and retention [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
    Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.

  • Magnitude and trajectory of changes in objective physical function [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
    Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data.


Secondary Outcome Measures:
  • Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
  • Self-reported quality of life [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: October 2012
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (physical activity)
Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.
 Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: counseling intervention
Receive lifestyle-related counseling
Other Name: counseling and communications studies
Behavioral: exercise intervention
Undergo physical activity intervention
Other: educational intervention
Receive educational materials
Other Name: intervention, educational
Active Comparator: Arm II (usual care)
Patients undergo usual care for 4 weeks.
 Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Procedure: standard follow-up care
Undergo usual care

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral intervention designed to improve physical function in older adults receiving chemotherapy for AML.

II. To estimate the effect size of the physical activity intervention on change in an objective measure of physical function, SPPB (short physical performance battery).

SECONDARY OBJECTIVES:

I. To estimate the effects of the physical activity intervention on self-reported physical function, health-related quality of life, and symptoms (depression, distress, fatigue).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.

ARM II: Patients undergo usual care for 4 weeks.

After completion of study treatment, patients are followed up every two weeks for two months and then monthly until week 24.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of AML with pathologic confirmation by World Health Organization (WHO) criteria
  • Planned induction chemotherapy
  • Absence of active medical problems that preclude participation in exercise (including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability, uncontrolled pain)
  • Patient must be ambulatory or able to walk with a cane
  • Patients must have limited cognitive deficits (< 3 incorrect responses on the Pfeiffer Mental Status Scale)
  • Adequate English skills to understand and complete questionnaires
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Presence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)
  • Inability to ambulate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519596

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Heidi D. Klepin     336-716-4392     hklepin@wakehealth.edu    
Principal Investigator: Heidi D. Klepin            
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Heidi Klepin Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01519596     History of Changes
Other Study ID Numbers: CCCWFU 97711, NCI-2012-00003
Study First Received: January 20, 2012
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Leukemia
Leukemia, Myeloid, Acute
 Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013