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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00554489 |
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 |
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Leukemia |
Procedure: exercise intervention Procedure: management of therapy complications Procedure: medical chart review Procedure: quality-of-life assessment Procedure: questionnaire administration |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia |
Estimated Enrollment: | 20 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Suzanne C. Danhauer, PhD | Wake Forest University |
Investigator: | Heidi D. Klepin, MD | Wake Forest University |
Investigator: | Shannon Mihalko, PhD | Wake Forest University |
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 |
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) |
Leukemia Acute myelogenous leukemia Acute myeloid leukemia, adult Leukemia, Myeloid |
Congenital Abnormalities Leukemia, Myeloid, Acute Acute myelocytic leukemia Recurrence |
Neoplasms Neoplasms by Histologic Type |