Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes
| Tracking Information | |||||
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| First Received Date ICMJE | July 12, 2007 | ||||
| Last Updated Date | October 23, 2012 | ||||
| Start Date ICMJE | May 2007 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2. [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00501449 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes | ||||
| Official Title ICMJE | Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes | ||||
| Brief Summary | The specific aims of the study include:
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with a diagnosis of MEN1 or MEN2. |
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| Condition ICMJE | Multiple Endocrine Neoplasia | ||||
| Intervention ICMJE | Behavioral: Questionnaire
Mailed packets including cover letter describing purpose of study, study questionnaire, and return envelope.
Other Name: Survey |
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| Study Group/Cohort (s) | MEN
Patients with multiple endocrine neoplasia (MEN).
Intervention: Behavioral: Questionnaire |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 581 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1) Inability to be contacted via mail (i.e., no contact information on record, incorrect address) |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00501449 | ||||
| Other Study ID Numbers ICMJE | 2006-0783 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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