Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353106
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2006-07-13
Brief Title:
Experience of Having Chronic Graft-Versus-Host Disease
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
The Experience of Having Chronic Graft-Versus-Host Disease
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Primary Objectives
1 To explore the experience of chronic graft-versus-host disease cGVHD following allogeneic blood or marrow transplantation from the perspective of the patient and the patients primary family caregiver
2 To develop and validate an instrument to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients who have cGVHD
Secondary Objectives
1 To develop a detailed description of the experience of having cGVHD
2 To develop a detailed description of the symptom experience of cGVHD to allow for development of a symptoms instrument for cGVHD
3 To assess the understanding of questions to measure the symptoms of cGVHD in patients with various levels of education
4 To develop a detailed description of caring for a patient with cGVHD
1 To explore the experience of chronic graft-versus-host disease cGVHD following allogeneic blood or marrow transplantation from the perspective of the patient and the patients primary family caregiver
2 To develop and validate an instrument to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients who have cGVHD
Secondary Objectives
1 To develop a detailed description of the experience of having cGVHD
2 To develop a detailed description of the symptom experience of cGVHD to allow for development of a symptoms instrument for cGVHD
3 To assess the understanding of questions to measure the symptoms of cGVHD in patients with various levels of education
4 To develop a detailed description of caring for a patient with cGVHD
Detailed Description:
For Patient
If you agree to take part in this study you will be asked to take part in 1 interview During the interview you will be asked to describe what it has been like for you to have chronic GVHD In addition if you agree to take part in this study your family caregiver if you have one will be approached to take part in the study
For Caregiver
If you agree to take part in this study you will be asked to take part in 1 interview During the interview you will be asked to describe what it has been like for you to help care for a family member with chronic GVHD
Both Parties
The interview face-to-face will take place while you are at M D Anderson receiving care You will be interviewed alone and the information gathered during the interview will be strictly confidential The interview will take about 30 minutes and will be tape recorded The audiotape of the interview will be kept in a locked cabinet in the office of the study chairperson Dr Loretta Williams If other study personnel need the tape for analysis they must obtain the tape directly from Dr Williams They may keep the tape only while they are listening to it and must return it immediately to Dr Williams Identification labels on the tape will only contain your study number and will not contain your name medical record number or other identifying information When all analysis for the study has been completed and reported the audiotape will be destroyed
After the interview you will be asked to answer a face-to-face questionnaire This questionnaire will ask descriptive personal information age marital status etc Answering these questions should take about 5 minutes
Your participation on this study ends after you complete the interview and questionnaire
This is an investigational study About 20 patients and 20 caregivers will take part in this study All will be enrolled at M D Anderson
For Patient - Phase III
If you agree to take part in this study you will be asked to complete 1 questionnaire The questionnaire will have questions asking you to rate how severe your current symptoms are and how much these symptoms disrupt your daily activities You will be asked to complete this questionnaire during your clinic visit The questionnaire will take no more than 10 minutes to complete
If you have chronic graft-versus-host disease you will be asked to complete a second questionnaire about your opinion of the symptom questionnaire the first questionnaire For example you will be asked if the symptom questionnaire was easy to understand and to complete Learning your opinion about this questionnaire will help researchers learn what important questions may be missing from the questionnaire The questionnaire will take no more than 10 minutes to complete
If you have chronic graft-versus-host disease you will also be given questions asking you to rate the overall quality of your life and your ability to function These ratings should take no more than 2 minutes to complete
Finally you will be asked to answer a questionnaire This questionnaire will ask descriptive personal information such as age and marital status Answering these questions should take about 5 minutes
If you have chronic GVHD you may be asked to fill out the questionnaire rating your symptoms 1 more time about 3 days after you completed it the first time You will return this second questionnaire to the research staff in a pre-addressed stamped envelope given to you by the research staff If you are asked to complete the questionnaire this second time the research staff will also ask for your telephone number so that they may contact you and remind you to complete the questionnaire
Identification labels on all study questionnaires and forms will only contain your study number and will not contain your name medical record number or other identifying information All study materials will be kept in a locked cabinet at all times When all analysis for the study has been completed and reported the questionnaires will be destroyed
The study ends when you have completed the questionnaires rating scales and interview in the clinic or when you have completed and returned the second questionnaire 3 days after your clinic visit
This is an investigational study Up to 192 patients will take part in this study 147 will be enrolled at M D Anderson and 45 will be enrolled at Roswell Park Cancer Institute
If you agree to take part in this study you will be asked to take part in 1 interview During the interview you will be asked to describe what it has been like for you to have chronic GVHD In addition if you agree to take part in this study your family caregiver if you have one will be approached to take part in the study
For Caregiver
If you agree to take part in this study you will be asked to take part in 1 interview During the interview you will be asked to describe what it has been like for you to help care for a family member with chronic GVHD
Both Parties
The interview face-to-face will take place while you are at M D Anderson receiving care You will be interviewed alone and the information gathered during the interview will be strictly confidential The interview will take about 30 minutes and will be tape recorded The audiotape of the interview will be kept in a locked cabinet in the office of the study chairperson Dr Loretta Williams If other study personnel need the tape for analysis they must obtain the tape directly from Dr Williams They may keep the tape only while they are listening to it and must return it immediately to Dr Williams Identification labels on the tape will only contain your study number and will not contain your name medical record number or other identifying information When all analysis for the study has been completed and reported the audiotape will be destroyed
After the interview you will be asked to answer a face-to-face questionnaire This questionnaire will ask descriptive personal information age marital status etc Answering these questions should take about 5 minutes
Your participation on this study ends after you complete the interview and questionnaire
This is an investigational study About 20 patients and 20 caregivers will take part in this study All will be enrolled at M D Anderson
For Patient - Phase III
If you agree to take part in this study you will be asked to complete 1 questionnaire The questionnaire will have questions asking you to rate how severe your current symptoms are and how much these symptoms disrupt your daily activities You will be asked to complete this questionnaire during your clinic visit The questionnaire will take no more than 10 minutes to complete
If you have chronic graft-versus-host disease you will be asked to complete a second questionnaire about your opinion of the symptom questionnaire the first questionnaire For example you will be asked if the symptom questionnaire was easy to understand and to complete Learning your opinion about this questionnaire will help researchers learn what important questions may be missing from the questionnaire The questionnaire will take no more than 10 minutes to complete
If you have chronic graft-versus-host disease you will also be given questions asking you to rate the overall quality of your life and your ability to function These ratings should take no more than 2 minutes to complete
Finally you will be asked to answer a questionnaire This questionnaire will ask descriptive personal information such as age and marital status Answering these questions should take about 5 minutes
If you have chronic GVHD you may be asked to fill out the questionnaire rating your symptoms 1 more time about 3 days after you completed it the first time You will return this second questionnaire to the research staff in a pre-addressed stamped envelope given to you by the research staff If you are asked to complete the questionnaire this second time the research staff will also ask for your telephone number so that they may contact you and remind you to complete the questionnaire
Identification labels on all study questionnaires and forms will only contain your study number and will not contain your name medical record number or other identifying information All study materials will be kept in a locked cabinet at all times When all analysis for the study has been completed and reported the questionnaires will be destroyed
The study ends when you have completed the questionnaires rating scales and interview in the clinic or when you have completed and returned the second questionnaire 3 days after your clinic visit
This is an investigational study Up to 192 patients will take part in this study 147 will be enrolled at M D Anderson and 45 will be enrolled at Roswell Park Cancer Institute
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