Expired Study
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Bethesda, Maryland 20892


Purpose:

This study will examine the quality of life of patients undergoing bone marrow transplantation to treat a blood disease. It will look at how this therapy affects many areas of life, including for example, personal relationships, work, and general emotional state. The information gained may lead to improved ways of dealing with problems that may arise before or during treatment. Patients receiving bone marrow stem cells donated by a family member may participate in this study. They will be interviewed before treatment begins and will complete questionnaires at the following intervals: 1. day of admission to the hospital 2. day of the transplant 3. 30 days after the transplant 4. 100 days after the transplant 5. 1 year after therapy 6. 2 years after therapy All questionnaires to be completed after discharge from the hospital will be scheduled during a regular follow-up visit. Each questionnaire takes about 15 to 20 minutes to complete. The information provided is confidential and will not be shared.


Study summary:

Clinical research in blood stem cell and bone marrow transplantation documents improvements in disease free intervals, disease free survival, and the severity of treatment related toxicities. However, it is important for patients and families to know the quality of life (QOL) they can expect following an allogeneic transplant. In this longitudinal study we will compare the QOL of patients undergoing a non-myeloablative allogeneic peripheral blood stem cell transplant (A-PBSCT) prospectively with that of a myeloablative A-PBSCT. Subjects (n=106) over the age of 18 will be enrolled. Measures of quality of life (Medical Outcomes Study Short Form-MOS SF-36 and Functional Assessment of Cancer Therapy-General and Bone Marrow Transplant - FACT-G and FACT-G/BMT) and symptom distress (Symptom Distress Scale - SDS) will be administered prior to transplant (baseline) and at set interval post transplant. Data will be analyzed using repeated measures analysis of variance and regression analysis.


Criteria:

INCLUSION CRITERIA: Male or female subjects 18 years of age or older. Able to read English or Spanish. Hematological disease requiring A-PBSCT. Signed informed consent for QOL study.


Study is Available At:


Original ID:

000002


NCT ID:

NCT00004994


Secondary ID:

00-CC-0002


Study Acronym:


Brief Title:

Comparison of Quality of Life in Patients Undergoing More Intensive Versus Less Intensive Chemotherapy and Radiation Preceding a Bone Marrow Transplan


Official Title:

A Study Comparing Quality of Life in Patients Undergoing a Non-Myeloablative Versus a Myeloablative Peripheral Blood Stem Cell Transplant for Hematological Diseases


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

106


Enrollment Type:


Study Dates

Start Date:October 1999
Completion Date:October 2004
Verification Date:October 2004
Last Changed Date:March 3, 2008
First Received Date:March 22, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institutes of Health Clinical Center (CC)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Baker F, Wingard JR, Curbow B, Zabora J, Jodrey D, Fogarty L, Legro M. Quality of life of bone marrow transplant long-term survivors. Bone Marrow Transplant. 1994 May;13(5):589-96.
PMID:8054912
Reference Type:Reference
Citation:Andrykowski MA, Altmaier EM, Barnett RL, Otis ML, Gingrich R, Henslee-Downey PJ. The quality of life in adult survivors of allogeneic bone marrow transplantation. Correlates and comparison with matched renal transplant recipients. Transplantation. 1990 Sep;50(3):399-406.
PMID:2402788
Reference Type:Reference
Citation:Andrykowski MA, Henslee PJ, Farrall MG. Physical and psychosocial functioning of adult survivors of allogeneic bone marrow transplantation. Bone Marrow Transplant. 1989 Jan;4(1):75-81.
PMID:2647190

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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