A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT00445731

First received: March 7, 2007

Last updated: October 16, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2007

Last Updated Date

October 16, 2012

Start Date ^ICMJE

May 2002

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Difference in functional status as measured by Karnofsky performance scores at day 0 of allogeneic bone marrow transplantation and at day 100 post-transplantation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00445731 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant

Official Title ^ICMJE

A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of Adult Allogeneic Donor Bone Marrow Transplant Patients

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.

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

Compare the effects of these regimens on patient survival at day 100 and at 1 year after transplantation.
Compare patient satisfaction with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention arms.

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.
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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Supportive Care

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Behavioral: exercise intervention
Procedure: management of therapy complications
Procedure: observation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

115

Completion Date

February 2006

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following malignancies:
- Acute lymphocytic leukemia
- Chronic myelogenous leukemia
- Acute myeloid leukemia
- Hodgkin's lymphoma
- Non-Hodgkin's lymphoma
- Myelodysplastic syndromes
- Other malignancy
Undergoing concurrent allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

Able to walk

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00445731

Other Study ID Numbers ^ICMJE

2002NT039, UMN-2002LB039, UMN-BMT-MT2002-04S

Has Data Monitoring Committee

Responsible Party

Masonic Cancer Center, University of Minnesota

Study Sponsor ^ICMJE

Masonic Cancer Center, University of Minnesota

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Todd Defor, MS

Masonic Cancer Center, University of Minnesota

Information Provided By

Masonic Cancer Center, University of Minnesota

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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