Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004994
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-03-22
Brief Title:
Comparison of Quality of Life in Patients Undergoing More Intensive Versus Less Intensive Chemotherapy and Radiation Preceding a Bone Marrow Transplant
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 n106 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-GBMT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CC-0002 | None | None | None |