Overview

This trial is active, not recruiting.

Conditions 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
Treatments quality-of-life assessment, counseling intervention, exercise intervention, educational intervention, standard follow-up care
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date October 2012
End date December 2016
Trial size 70 participants
Trial identifier NCT01519596, CCCWFU 97711, NCI-2012-00003

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
quality-of-life assessment quality of life assessment
Ancillary studies
counseling intervention counseling and communications studies
Receive lifestyle-related counseling
exercise intervention
Undergo physical activity intervention
educational intervention intervention, educational
Receive educational materials
(Active Comparator)
Patients undergo usual care for 4 weeks.
quality-of-life assessment quality of life assessment
Ancillary studies
standard follow-up care
Undergo usual care

Primary Outcomes

Measure
Feasibility, in terms of participation rates and barriers to recruitment and retention
time frame: Approximately 4 weeks
Magnitude and trajectory of changes in objective physical function
time frame: Approximately 4 weeks

Secondary Outcomes

Measure
Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength
time frame: Approximately 4 weeks
Self-reported quality of life
time frame: Approximately 24 weeks

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
Principal investigator Heidi Klepin
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.