Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes

November 17, 2020 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of MEN1 or MEN2.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Survey

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan Peterson, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2007

Primary Completion (Actual)

September 22, 2020

Study Completion (Actual)

September 22, 2020

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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