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Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00501449
Recruitment Status : Active, not recruiting
First Posted : July 16, 2007
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Multiple Endocrine Neoplasia Behavioral: Questionnaire

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 : Observational
Estimated Enrollment : 581 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes
Actual Study Start Date : May 2007
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Multiple Endocrine Neoplasia (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

Primary Outcome Measures :
  1. Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2. [ Time Frame: 3 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of MEN1 or MEN2.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501449

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501449     History of Changes
Other Study ID Numbers: 2006-0783
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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