Disorder Related to Bone Marrow TransplantationNCT00667784
Long Term Minor Sibling Donor Well-Being
An observational study of Disorder Related to Bone Marrow Transplantation and Blood Stem Cell Transplant Failure, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to understand what it is like for a young person to have a sick family member and what it is like to donate bone marrow or stem cells for a sick family member. Primary Aims: 1. Read more about this study
- Who is it for?
- Ages 5 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder Related to Bone Marrow Transplantation, Blood Stem Cell Transplant Failure, Disturbance of Emotions Specific to Childhood and Adolescence
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2011
- 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 5 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Parent, legal guardian, or sibling of a patient that will have a bone marrow or stem cell transplant.
Who may be able to join
- sibling of an allogeneic cell therapy transplant patient -- the persons receiving allogeneic transplant may have either an acquired or congenital disease. Acquired diseases include acute lymphoblastic leukemia, acute myelogenous leukemia, severe aplastic anemia, hemoglobinopathies, and lymphomas.Congenital diseases are comprised of hemoglobinopathies and glycogen/lysosomal disorders. Transplant is being considered after failure to respond to traditional therapies or due to the nature of the disease.
- 5 to 19 years of age
- speaks English or Spanish
- one parent or legal guardian willing to participate
- mentally able to render a valid assessment
- donor is harvested at this institution
- donors will participate in the standard psychosocial intervention
- children in the non-donor group will be matched by age and gender to donor group participants
Who cannot join
- participation is limited to one donor per family
- if a child had matched and declined to donate, that child would not be eligible to participate in the non-donor group
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research study is to understand what it is like for a young person to have a sick family member and what it is like to donate bone marrow or stem cells for a sick family member.
Primary Aims:
Read more
- Compare minor donor adjustment to minor non-donor adjustment, including anxiety, self-esteem, traumatic stress, achievement, and behavior.
- Evaluate minor donor adjustment across time, including self -esteem, traumatic stress, anxiety, achievement, and behavior.
- Investigate the effect of the following on donor well-being:
- Donor variables: 1) the impact of the harvest, including type of harvest (needle aspiration of bone marrow or peripheral blood stem cell collection by apheresis after injection of G-CSF), pre-procedural anxiety and perceived pain; 2) age of donor at time of transplant, 3) gender, 4) preparedness for transplant, 5) sibling order (for sibling participants), and 6) donor's decision-making and ambivalence regarding donation.
- Recipient variables: 1) the recipient's level of well-being or death, 2) genetic versus acquired disease types, and 3) familial relationship of donor to recipient.
- Family support variables: 1) the distress of the family, 2) the quality of the relationship between the potential donor and the recipient, and 3) parent's well-being (post-traumatic stress disorder or PTSD, depression).
Secondary Aim:
Evaluate satisfaction with the donor program.
Read the detailed description
FOR PARENT or Legal Guardian:
Half of the young persons being asked to participate in this study will be donating bone marrow or stem cells and will be referred to as "minor donors." The other half will not be donating marrow or cells but have a sick family member who will be having a bone marrow or stem cell transplant and will be referred to as "non-donors". For each participating young person, one parent or legal guardian will need to complete the parent questionnaires as well.
You are being asked to participate in this study because you have a sick family member who will have a bone marrow or stem cell transplant at this hospital and you are a caregiver to a healthy child. You will be asked to complete 5 questionnaires shortly before the bone marrow or stem cells are collected, shortly after the transplant, and 6 months after the transplant. You will be asked about your children, family atmosphere, and parental well-being. Most of the questions have a list of possible answers, and you will choose the answer that best describes you. Some questions are left blank for you to write in your answer. It will take about 45 minutes to complete the questionnaires.
FOR CHILD:
If you agree to take part in this study, you will be asked to complete 9 questionnaires shortly before the bone marrow or stem cells are collected, shortly after the transplant, and 6 months after the transplant. You would be asked about your feelings, behavior, and how you are doing in school. These types of questions do not have wrong answers. Most of the questions have a list of possible answers, and you will choose the answer that best describes you. Some questions are left blank for you to write in your answer. It will take about 1 hour to fill out the questionnaires.
Length of Study:
You will participate in the study across a 7 month period. You will begin the study one month before donation and complete the study 6 months after the donation.
This is an investigational study. Up to 30 participants (15 minor donor's parents and 15 non-donor's parents) will be enrolled on this study. All will be enrolled at M. D. Anderson.
- Conditions
- Disorder Related to Bone Marrow Transplantation, Blood Stem Cell Transplant Failure, Disturbance of Emotions Specific to Childhood and Adolescence, Transmission, Blood, Recipient/Donor, Sibling
- Being tested
- Questionnaire
- Keywords
- pediatric stem cell donor, emotional sequelae, physical sequelae, psychological consequences of minor donation, Bone Marrow Transplantation, Questionnaire, Survey, Sibling Donor, Stem Cell Transplant, Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Assessment | Minor Donors + Sibling Non-Donors + Parents or Legal Guardians Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Donor Status on Child's Anxiety (Sibling Donor vs. Sibling Non-Donor)
Comparison of the two groups (i.e., donor vs. non-donor) using Revised Children's Manifest Anxiety Scale (RCMAS) administered prior to transplant, and two times during course of study to ascertain anxiety. The longitudinal nature of the data necessitates use of a multivariable repeated measures model to examine effects of donor vs. non-donor status on anxiety.
Measured: 7 months (one month pre-donation; one month post-donation; 6 months post-donation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Bone Marrow TransplantationStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rhonda Robert, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667784
- Sponsor's protocol ID
- 2007-0571
- Status last verified
- Mar 2012
- First submitted
- 24 Apr 2008
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Minor Sibling Donor Well-Being
- ClinicalTrials.gov ID
- NCT00667784
- Acronym / sponsor ID
- 2007-0571
- Conditions
- Disorder Related to Bone Marrow Transplantation, Blood Stem Cell Transplant Failure, Disturbance of Emotions Specific to Childhood and Adolescence, Transmission, Blood, Recipient/Donor, Sibling
- Keywords
- pediatric stem cell donor, emotional sequelae, physical sequelae, psychological consequences of minor donation, Bone Marrow Transplantation, Questionnaire, Survey, Sibling Donor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 28 Apr 2008 (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.
The goal of this research study is to understand what it is like for a young person to have a sick family member and what it is like to donate bone marrow or stem cells for a sick family member.
Primary Aims:
- Compare minor donor adjustment to minor non-donor adjustment, including anxiety, self-esteem, traumatic stress, achievement, and behavior.
- Evaluate minor donor adjustment across time, including self -esteem, traumatic stress, anxiety, achievement, and behavior.
- Investigate the effect of the following on donor well-being:
- Donor variables: 1) the impact of the harvest, including type of harvest (needle aspiration of bone marrow or peripheral blood stem cell collection by apheresis after injection of G-CSF), pre-procedural anxiety and perceived pain; 2) age of donor at time of transplant, 3) gender, 4) preparedness for transplant, 5) sibling order (for sibling participants), and 6) donor's decision-making and ambivalence regarding donation.
- Recipient variables: 1) the recipient's level of well-being or death, 2) genetic versus acquired disease types, and 3) familial relationship of donor to recipient.
- Family support variables: 1) the distress of the family, 2) the quality of the relationship between the potential donor and the recipient, and 3) parent's well-being (post-traumatic stress disorder or PTSD, depression).
Secondary Aim:
Evaluate satisfaction with the donor program.
Detailed description
FOR PARENT or Legal Guardian:
Half of the young persons being asked to participate in this study will be donating bone marrow or stem cells and will be referred to as "minor donors." The other half will not be donating marrow or cells but have a sick family member who will be having a bone marrow or stem cell transplant and will be referred to as "non-donors". For each participating young person, one parent or legal guardian will need to complete the parent questionnaires as well.
You are being asked to participate in this study because you have a sick family member who will have a bone marrow or stem cell transplant at this hospital and you are a caregiver to a healthy child. You will be asked to complete 5 questionnaires shortly before the bone marrow or stem cells are collected, shortly after the transplant, and 6 months after the transplant. You will be asked about your children, family atmosphere, and parental well-being. Most of the questions have a list of possible answers, and you will choose the answer that best describes you. Some questions are left blank for you to write in your answer. It will take about 45 minutes to complete the questionnaires.
FOR CHILD:
If you agree to take part in this study, you will be asked to complete 9 questionnaires shortly before the bone marrow or stem cells are collected, shortly after the transplant, and 6 months after the transplant. You would be asked about your feelings, behavior, and how you are doing in school. These types of questions do not have wrong answers. Most of the questions have a list of possible answers, and you will choose the answer that best describes you. Some questions are left blank for you to write in your answer. It will take about 1 hour to fill out the questionnaires.
Length of Study:
You will participate in the study across a 7 month period. You will begin the study one month before donation and complete the study 6 months after the donation.
This is an investigational study. Up to 30 participants (15 minor donor's parents and 15 non-donor's parents) will be enrolled on this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anxiety Assessment | – | Behavioral: QuestionnaireMinor Donors + Sibling Non-Donors + Parents or Legal Guardians |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Parent, legal guardian, or sibling of a patient that will have a bone marrow or stem cell transplant.
Key inclusion criteria (8 listed)
- sibling of an allogeneic cell therapy transplant patient -- the persons receiving allogeneic transplant may have either an acquired or congenital disease. Acquired diseases include acute lymphoblastic leukemia, acute myelogenous leukemia, severe aplastic anemia, hemoglobinopathies, and lymphomas.Congenital diseases are comprised of hemoglobinopathies and glycogen/lysosomal disorders. Transplant is being considered after failure to respond to traditional therapies or due to the nature of the disease.
- 5 to 19 years of age
- speaks English or Spanish
- one parent or legal guardian willing to participate
- mentally able to render a valid assessment
Key exclusion criteria (2 listed)
- participation is limited to one donor per family
- if a child had matched and declined to donate, that child would not be eligible to participate in the non-donor group
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 |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant. | Behavioural | Anxiety Assessment |
Primary outcome
Effect of Donor Status on Child's Anxiety (Sibling Donor vs. Sibling Non-Donor)
Time frame: 7 months (one month pre-donation; one month post-donation; 6 months post-donation)
Comparison of the two groups (i.e., donor vs. non-donor) using Revised Children's Manifest Anxiety Scale (RCMAS) administered prior to transplant, and two times during course of study to ascertain anxiety. The longitudinal nature of the data necessitates use of a multivariable repeated measures model to examine effects of donor vs. non-donor status on anxiety.
Results and safety
The study was stopped early (reason given: Slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- 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.
Rhonda Robert, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder Related to Bone Marrow Transplantation and Blood Stem Cell Transplant Failure, run by M.D. Anderson Cancer Center at 1 site 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 8 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Slow accrual.). Results are not available in the source record.
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?
Effect of Donor Status on Child's Anxiety (Sibling Donor vs. Sibling Non-Donor) (time frame: 7 months (one month pre-donation; one month post-donation; 6 months post-donation)). 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 2 Apr 2012.