Graft-Versus-Host DiseaseNCT00353106
Experience of Having Chronic Graft-Versus-Host Disease
An observational study of Graft-Versus-Host Disease, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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 patient's primary family caregiver. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- Interview and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 187 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants with chronic graft-versus-host disease (cGVHD) following allogeneic blood or marrow transplantation, the patient's primary family caregiver, and content expert panel.
Who may be able to join
- 18 years of age or older
- Ability to speak and read English
- Clinical or histological diagnosis of active cGVHD or at least 3 months post allogeneic BMT without a diagnosis of active GVHD (PATIENT ONLY)
- Identification as the single primary family caregiver by a patient with cGVHD (CAREGIVER ONLY)
- Physician or nurse with at least 5 years experience caring for patients with cGHVD (PROFESSIONAL EXPERT ONLY)
- At least one publication in the last 5 years dealing with cGVHD (PHYSICIAN PROFESSIONAL EXPERT ONLY)
- Consent to participate
Who cannot join
- Inability to understand the intent of the study
- Medical condition that would preclude participation in an interview lasting 30 minutes (PHASE 1 OF STUDY ONLY)
- Diagnosis of active psychosis or severe cognitive impairment
- Bone marrow or stem cell donor for patient (CAREGIVER ONLY)
- Disease for which BMT was performed not in remission (PATIENT ONLY)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
UT MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Experience of Having Chronic Graft-Versus-Host Disease
Primary Objectives:
- 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 patient's primary family caregiver.
- 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.
Read more
Secondary Objectives:
- To develop a detailed description of the experience of having cGVHD.
- To develop a detailed description of the symptom experience of cGVHD to allow for development of a symptoms instrument for cGVHD.
- To assess the understanding of questions to measure the symptoms of cGVHD in patients with various levels of education.
- To develop a detailed description of caring for a patient with cGVHD.
Read the 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.
- Conditions
- Graft-Versus-Host Disease
- Being tested
- Interview, Questionnaire
- Keywords
- Graft-Versus-Host Disease, GVHD, Chronic Graft-Versus-Host Disease, cGVHD, Interview, Questionnaire, Survey, Caregiver
- Medical subject headings
- Graft vs Host Disease, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
30-minute interviews of participating patients and their caregiver(s).
QuestionnaireBehavioural
Also called Survey
Questionnaires that will take approximately 5 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with chronic GVHD Receives: Behavioral: Interview; Behavioral: Questionnaire | |
| Content Expert Panel | Content expert panel with 5 years experience caring for patients with cGVHD. Receives: Behavioral: Questionnaire | |
| Caregivers | Caregivers of patients with cGVHD Receives: Behavioral: Interview; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Open-Ended Interview/Questions designed to elicit specific descriptions of experience of having cGVHD or caring for a patient with cGVHD
Measured: At time of treatment, duration approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loretta A. Williams, DSN, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353106
- Sponsor's protocol ID
- 2005-0727
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2006
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience of Having Chronic Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT00353106
- Acronym / sponsor ID
- 2005-0727
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Graft-Versus-Host Disease, GVHD, Chronic Graft-Versus-Host Disease, cGVHD, Interview, Questionnaire, Survey, Caregiver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- 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 patient's primary family caregiver.
- 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:
- To develop a detailed description of the experience of having cGVHD.
- To develop a detailed description of the symptom experience of cGVHD to allow for development of a symptoms instrument for cGVHD.
- To assess the understanding of questions to measure the symptoms of cGVHD in patients with various levels of education.
- 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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: Interview, Behavioral: QuestionnairePatients with chronic GVHD |
| Content Expert Panel | – | Behavioral: QuestionnaireContent expert panel with 5 years experience caring for patients with cGVHD. |
| Caregivers | – | Behavioral: Interview, Behavioral: QuestionnaireCaregivers of patients with cGVHD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants with chronic graft-versus-host disease (cGVHD) following allogeneic blood or marrow transplantation, the patient's primary family caregiver, and content expert panel.
Key inclusion criteria (7 listed)
- 18 years of age or older
- Ability to speak and read English
- Clinical or histological diagnosis of active cGVHD or at least 3 months post allogeneic BMT without a diagnosis of active GVHD (PATIENT ONLY)
- Identification as the single primary family caregiver by a patient with cGVHD (CAREGIVER ONLY)
- Physician or nurse with at least 5 years experience caring for patients with cGHVD (PROFESSIONAL EXPERT ONLY)
Key exclusion criteria (5 listed)
- Inability to understand the intent of the study
- Medical condition that would preclude participation in an interview lasting 30 minutes (PHASE 1 OF STUDY ONLY)
- Diagnosis of active psychosis or severe cognitive impairment
- Bone marrow or stem cell donor for patient (CAREGIVER ONLY)
- Disease for which BMT was performed not in remission (PATIENT ONLY)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview30-minute interviews of participating patients and their caregiver(s). | Behavioural | Caregivers, Patients |
| QuestionnaireAlso: SurveyQuestionnaires that will take approximately 5 minutes to complete. | Behavioural | Caregivers, Content Expert Panel, Patients |
Primary outcome
Phase 1: Open-Ended Interview/Questions designed to elicit specific descriptions of experience of having cGVHD or caring for a patient with cGVHD
Time frame: At time of treatment, duration approximately 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loretta A. Williams, DSN principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft-Versus-Host Disease, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Open-Ended Interview/Questions designed to elicit specific descriptions of experience of having cGVHD or caring for a patient with cGVHD (time frame: At time of treatment, duration approximately 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.