A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant
Study Details
Study Description
Brief Summary
RATIONALE: A walking program may improve the ability to carry out daily activities after donor bone marrow transplant.
PURPOSE: This randomized clinical trial is studying a structured walking program to see how well it works compared with standard therapy in cancer patients undergoing a donor bone marrow transplant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
Primary
- Compare the effects of a structured walking regimen vs normal standard care on functional status at day 100 after allogeneic bone marrow transplantation in patients with cancer.
Secondary
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Compare the effects of these regimens on patient survival at day 100 and at 1 year after transplantation.
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Compare patient satisfaction with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention arms.
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Arm I: Beginning 2-3 days after allogeneic bone marrow transplantation, patients walk on a treadmill or in the hospital hallways twice daily for ≥ 15 minutes. After discharge and continuing for up to 100 days post-transplantation, patients walk once daily for ≥ 30 minutes. Patients record their walking times daily in a journal.
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Arm II: Patients receive no special instructions regarding exercise other than the normal standard of care.
All patients complete questionnaires at discharge and at day 100 post-transplantation measuring daily exercise activities, satisfaction with the recommended walking regimen, and functional status.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Study Design
Outcome Measures
Primary Outcome Measures
- Difference in functional status as measured by Karnofsky performance scores at day 0 of allogeneic bone marrow transplantation and at day 100 post-transplantation []
Secondary Outcome Measures
- Survival at day 100 and at 1 year post-transplantation []
- Patient satisfaction with the suggested exercise regimen as measured by the Wilcoxon test using a 5-point rating scale []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of 1 of the following malignancies:
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Acute lymphocytic leukemia
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Chronic myelogenous leukemia
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Acute myeloid leukemia
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Hodgkin's lymphoma
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Non-Hodgkin's lymphoma
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Myelodysplastic syndromes
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Other malignancy
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Undergoing concurrent allogeneic bone marrow transplantation
PATIENT CHARACTERISTICS:
- Able to walk
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Minnesota
Investigators
- Study Chair: Todd Defor, MS, Masonic Cancer Center, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2002NT039
- UMN-2002LB039
- UMN-BMT-MT2002-04S