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Content Validation of Quality of Life and Symptom Questionnaires for Pheochromocytoma and Paraganglioma
This study has been terminated.
Sponsor:
Molecular Insight Pharmaceuticals, Inc.
Information provided by:
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00911729
First received: May 29, 2009
Last updated: June 7, 2013
Last verified: June 2013
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Purpose
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 |
|---|
| Pheochromocytoma Paraganglioma |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary paraganglioma-pheochromocytoma
nonsyndromic paraganglioma
MedlinePlus related topics:
Pheochromocytoma
Genetic and Rare Diseases Information Center resources:
Pheochromocytoma
Paragangliomas 1
Carotid Body Tumor
Carcinoid Tumor
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2009 |
Eligibility| 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 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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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: NCT00911729
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911729
Locations
| United States, Maryland | |
| Oxford Outcomes- Nationwide Recruitment within the US | |
| Bethesda, Maryland, United States, 20814 | |
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Emuella M Flood, BS | Oxford Outcomes |
More Information
| Responsible Party: | Meredith Frank-Molnia, Molecular Insight Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00911729 History of Changes |
| Other Study ID Numbers: |
A1970 |
| Study First Received: | May 29, 2009 |
| Last Updated: | June 7, 2013 |
Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
|
paraganglioma pheochromocytoma |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 21, 2017