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Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00501449
First received: July 12, 2007
Last updated: October 27, 2014
Last verified: October 2014
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes

Resource links provided by NLM:


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: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 581
Study Start Date: May 2007
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MEN
Patients with multiple endocrine neoplasia (MEN).
Behavioral: Questionnaire
Mailed packets including cover letter describing purpose of study, study questionnaire, and return envelope.
Other Name: Survey

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:

  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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501449

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501449     History of Changes
Other Study ID Numbers: 2006-0783
Study First Received: July 12, 2007
Last Updated: October 27, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Neoplasms
Syndrome
Disease
Endocrine System Diseases
Genetic Diseases, Inborn
Neoplasms by Site
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014