- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00501449
Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes
The specific aims of the study include:
- Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2.
- Evaluate MEN-specific distress as well as adherence to surveillance regimens among adults with MEN1 or MEN2, and identify associated with those outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed cross-sectional study is intended to obtain information regarding current surveillance behaviors and other psychosocial outcomes among persons affected by the multiple endocrine neoplasia (MEN) 1 or MEN2, which are inherited conditions.
Study participants will include patients who have been seen previously at MDACC for evaluation of MEN1 or MEN2. Because this is the first time investigators are contacting these patients to invite them to participate in psychosocial research, the proposed study also will help determine the feasibility of conducting similar studies in the future.
Investigators anticipate that data gathered from this study will enhance existing knowledge about the psychological and behavioral aspects of the MEN syndromes, and will inform future research efforts directed toward this understudied population.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults age 18 years or older, with a clinical or genetic diagnosis of MEN1 or MEN2
- Spouse, Significant Other, or Family Member who is at least 18 years of age and who is related to an individual who is a patient at MDACC and who has been diagnosed with MEN1.
- Ability to read and write English
Exclusion Criteria:
1) Inability to be contacted via mail (i.e., no contact information on record, incorrect address)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Multiple Endocrine Neoplasia (MEN)
Patients with multiple endocrine neoplasia (MEN).
|
Mailed packets including cover letter describing purpose of study, study questionnaire, and return envelope.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2.
Time Frame: 3 Years
|
3 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan Peterson, PhD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-0783
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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