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

Bone Marrow Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004994
• Other study ID #: 000002
• Secondary ID: 00-CC-0002
• Status: Completed
• Phase: N/A
• First received: March 22, 2000
• Last updated: March 3, 2008
• Start date: October 1999
• Est. completion date: October 2004

Study information

• Verified date: October 2004
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Bone Marrow Transplantation

Locations

Country	Name	City	State
United States	Warren G. Magnuson Clinical Center (CC)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation