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Content Validation of Quality of Life and Symptom Questionnaires for Pheochromocytoma and Paraganglioma

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: NCT00911729
Recruitment Status : Terminated
First Posted : June 2, 2009
Last Update Posted : June 10, 2013
Sponsor:
Information provided by:
Molecular Insight Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The purpose of this qualitative study is to evaluate the clarity and comprehensiveness of two disease-specific questionnaires, and to evaluate how effective these questionnaires are at assessing the quality of life and symptoms of patients with pheochromocytoma or paraganglioma.

Condition or disease
Pheochromocytoma Paraganglioma

Study Design
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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Content Validation of the EORTC QLQ-C30 Version 3.0, and NIH Quality of Life and Symptoms Questionnaire for Pheochromocytoma and Paraganglioma
Study Start Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pheochromocytoma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The main objective of this study is to evaluate content validity of the NIH Quality of Life and Symptoms Questionnaire for Pheochromocytoma and Paraganglioma and EORTC-QLQ-C30 in patients with pheochromocytoma or paraganglioma. [ Time Frame: Single Visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma with active symptoms or who are within 60 days of curative therapy
Criteria

Inclusion Criteria:

  • Provide written informed consent and be willing to comply with protocol requirements
  • Participant is aged ≥ 18
  • Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma with active symptoms or within 60 days of curative therapy

Exclusion Criteria:

Patient is currently asymptomatic from pheochromocytoma/paraganglioma diagnosis or duration > 60 days from curative therapy

  • Participant has a clinically significant disorder, including alcohol or drug abuse, which may interfere with study participation or which may affect the outcome of the study as judged by the investigator.
  • Participant has a mental disability or significant mental illness, legal incapacity or limited legal capacity or any other lack of fitness, in the investigator's opinion, to preclude the subject's participation in or ability to complete the study.
  • Participant is currently too unwell to take part in the study.
Contacts and Locations
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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): NCT00911729


Locations
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United States, Maryland
Oxford Outcomes- Nationwide Recruitment within the US
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Emuella M Flood, BS Oxford Outcomes
More Information
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Responsible Party: Meredith Frank-Molnia, Molecular Insight Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00911729    
Other Study ID Numbers: A1970
First Posted: June 2, 2009    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: June 2013
Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
paraganglioma
pheochromocytoma
Additional relevant MeSH terms:
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Pheochromocytoma
Paraganglioma
Carotid Body Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Paraganglioma, Extra-Adrenal