CancerNCT00445731
A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant
A study testing exercise intervention, management of therapy complications and observation in people with Cancer, run by University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- exercise intervention, management of therapy complications and observation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of Adult Allogeneic Donor Bone Marrow Transplant Patients
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- exercise intervention, management of therapy complications, observation
- Keywords
- poor performance status, unspecified adult solid tumor, protocol specific, 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), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, atypical chronic myeloid leukemia, blastic phase chronic myelogenous leukemia, chronic eosinophilic leukemia, chronic idiopathic myelofibrosis, chronic myelomonocytic leukemia, chronic neutrophilic leukemia, chronic phase chronic myelogenous leukemia, de novo myelodysplastic syndromes, disseminated neuroblastoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- Medical subject headings
- Neoplasms, Congenital Abnormalities, Leukemia, Myeloid, Accelerated Phase, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Pdgfra-Associated Chronic Eosinophilic Leukemia, Primary Myelofibrosis, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
management of therapy complicationsProcedure or surgery
observationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startMay 2002
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Defor, MS, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445731
- Sponsor's protocol ID
- 2002NT039
- Other IDs
- UMN-2002LB039, UMN-BMT-MT2002-04S
- Status last verified
- Sep 2014
- First submitted
- 7 Mar 2007
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of Adult Allogeneic Donor Bone Marrow Transplant Patients
- ClinicalTrials.gov ID
- NCT00445731
- Acronym / sponsor ID
- 2002NT039
- Conditions
- Cancer
- Keywords
- poor performance status, unspecified adult solid tumor, protocol specific, 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), accelerated phase chronic myelogenous leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 9 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise intervention | Behavioural | – |
| management of therapy complications | Procedure or surgery | – |
| observation | Procedure or surgery | – |
Primary outcome
Difference in functional status as measured by Karnofsky performance scores at day 0 of allogeneic bone marrow transplantation and at day 100 post-transplantation
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Defor, MS study chair
Masonic Cancer Center, University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, management of therapy complications and observation in people with Cancer, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in functional status as measured by Karnofsky performance scores at day 0 of allogeneic bone marrow transplantation and at day 100 post-transplantation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.