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Psychosocial Aspects of MEN Syndromes
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501449
  Purpose

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.

Condition Intervention
Multiple Endocrine Neoplasia
Behavioral: Questionnaire

Genetics Home Reference related topics: multiple endocrine neoplasia
MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 239
Study Start Date: May 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with multiple endocrine neoplasia (MEN).
Behavioral: Questionnaire
Mailed packets including cover letter describing purpose of study, study questionnaire, and return envelope.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of MEN1 or MEN2.

Criteria

Inclusion Criteria:

  • Adults age 18 years or older, with a clinical or genetic diagnosis of MEN1 or MEN2
  • Ability to read and write English

Exclusion Criteria:

  • Inability to be contacted via mail (i.e., no contact information on record, incorrect address)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501449

Contacts
Contact: Susan Peterson, PhD 713-792-8267

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Susan Peterson, PhD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan Peterson, PhD U.T.M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Susan Peterson, PhD/Assistant Professor )
Study ID Numbers: 2006-0783
Study First Received: July 12, 2007
Last Updated: December 30, 2008
ClinicalTrials.gov Identifier: NCT00501449  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Endocrine Neoplasia
Questionnaire
Psychosocial
Surveillance Behaviors
MEN Syndromes

Study placed in the following topic categories:
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Endocrine System Diseases
Endocrinopathy
Multiple Endocrine Neoplasia
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Site
Syndrome
Neoplasms, Multiple Primary

ClinicalTrials.gov processed this record on January 14, 2009