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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00501449
Other study ID # 2006-0783
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2007
Est. completion date September 22, 2020

Study information

Verified date November 2020
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The specific aims of the study include: 1. Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2. 2. Evaluate MEN-specific distress as well as adherence to surveillance regimens among adults with MEN1 or MEN2, and identify associated with those outcomes.


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.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date September 22, 2020
Est. primary completion date September 22, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adults age 18 years or older, with a clinical or genetic diagnosis of MEN1 or MEN2 2. 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. 3. 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 Design


Intervention

Behavioral:
Questionnaire
Mailed packets including cover letter describing purpose of study, study questionnaire, and return envelope.

Locations

Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2. 3 Years
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