NeurofibromatosisNCT00508235
Quality of Friendships in Children With Neurofibromatosis
An observational study of Neurofibromatosis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The aim of this study is to determine if children with a higher disease severity have lower quality friendships than children who are less severely affected and children who are unaffected. Researchers will test the hypothesis that the quality of friendships is inversely related to their disease severity. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Neurofibromatosis
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jul 2009
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study participants with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old.
Who may be able to join
- 1) Patients with a clinical diagnosis of neurofibromatosis, type 1 (NF-1) who are between the ages of 8 and 18 years will be eligible. Patients must be English or Spanish speaking (test instrument will be translated into Spanish), and be able to read.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Quality of Friendships in Children With Neurofibromatosis: Relationship to Disease Severity
The aim of this study is to determine if children with a higher disease severity have lower quality friendships than children who are less severely affected and children who are unaffected. Researchers will test the hypothesis that the quality of friendships is inversely related to their disease severity.
Specific Aims:
- To use the FQQ to determine if the quality of friendships in children with NF1 is lower than the quality of friendships in unaffected children.
- To use a disease severity scale and the FQQ to determine if children who are less severely affected have higher friendship qualities than children who are more severely affected.
Read the detailed description
You (your) child will be asked to complete a short questionnaire (40 questions) about their relationship with their best friend. Doctors will review your (child's) medical chart to find out how severe the disease is, so that this may be compared to the answers you have (your child has) given on the friendship questionnaire.
This is an Investigational Study. About 90-100 children and adolescents with NF-1 will be asked to take part in this study. All will be enrolled at M.D. Anderson.
- Conditions
- Neurofibromatosis
- Being tested
- Questionnaire
- Keywords
- Neurofibromatosis, Quality of Friendships, Disease Severity, Questionnaire, NF-1
- Medical subject headings
- Neurofibromatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire about the patient's relationship with their best friend.
| Study group | Role | What they receive |
|---|---|---|
| Quality of Friendships | Patients with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity scale and Friendship Quality Questionnaire (FQQ)
Measured: Questionnaire completion by patient and chart review by doctor for disease severity scoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startDec 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurofibromatosisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartlett D. Moore, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508235
- Sponsor's protocol ID
- 2004-0791
- Status last verified
- Jul 2012
- First submitted
- 26 Jul 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Friendships in Children With Neurofibromatosis: Relationship to Disease Severity
- ClinicalTrials.gov ID
- NCT00508235
- Acronym / sponsor ID
- 2004-0791
- Conditions
- Neurofibromatosis
- Keywords
- Neurofibromatosis, Quality of Friendships, Disease Severity, Questionnaire, NF-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Jul 2007 (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 aim of this study is to determine if children with a higher disease severity have lower quality friendships than children who are less severely affected and children who are unaffected. Researchers will test the hypothesis that the quality of friendships is inversely related to their disease severity.
Specific Aims:
- To use the FQQ to determine if the quality of friendships in children with NF1 is lower than the quality of friendships in unaffected children.
- To use a disease severity scale and the FQQ to determine if children who are less severely affected have higher friendship qualities than children who are more severely affected.
Detailed description
You (your) child will be asked to complete a short questionnaire (40 questions) about their relationship with their best friend. Doctors will review your (child's) medical chart to find out how severe the disease is, so that this may be compared to the answers you have (your child has) given on the friendship questionnaire.
This is an Investigational Study. About 90-100 children and adolescents with NF-1 will be asked to take part in this study. All will be enrolled at M.D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of Friendships | – | Behavioral: QuestionnairePatients with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study participants with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old.
Key inclusion criteria (1 listed)
- 1) Patients with a clinical diagnosis of neurofibromatosis, type 1 (NF-1) who are between the ages of 8 and 18 years will be eligible. Patients must be English or Spanish speaking (test instrument will be translated into Spanish), and be able to read.
Key exclusion criteria (0 listed)
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: SurveyQuestionnaire about the patient's relationship with their best friend. | Behavioural | Quality of Friendships |
Primary outcome
Disease severity scale and Friendship Quality Questionnaire (FQQ)
Time frame: Questionnaire completion by patient and chart review by doctor for disease severity scoring.
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 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink 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.
Bartlett D. Moore, 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 Neurofibromatosis, 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 1 inclusion and 0 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 1 Aug 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 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?
Disease severity scale and Friendship Quality Questionnaire (FQQ) (time frame: Questionnaire completion by patient and chart review by doctor for disease severity scoring.). 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 1 Aug 2012.