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

Tracking Information
First Received Date ^ICMJE	March 22, 2000
Last Updated Date	March 3, 2008
Start Date ^ICMJE	October 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00004994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Comparison of Quality of Life in Patients Undergoing More Intensive Versus Less Intensive Chemotherapy and Radiation Preceding a Bone Marrow Transplant
Official Title ^ICMJE	A Study Comparing Quality of Life in Patients Undergoing a Non-Myeloablative Versus a Myeloablative Peripheral Blood Stem Cell Transplant for Hematological Diseases
Brief 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: day of admission to the hospital day of the transplant 30 days after the transplant 100 days after the transplant 1 year after therapy 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.
Detailed 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.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Bone Marrow Transplantation
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	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. 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. 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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	106
Completion Date	October 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00004994
Responsible Party
Study ID Numbers ^ICMJE	000002, 00-CC-0002
Study Sponsor ^ICMJE	National Institutes of Health Clinical Center (CC)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	October 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP