Content Validation of Quality of Life and Symptom Questionnaires for Pheochromocytoma and Paraganglioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Molecular Insight Pharmaceuticals, Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Molecular Insight Pharmaceuticals, Inc.
Information provided by:
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00911729
First received: May 29, 2009
Last updated: June 1, 2009
Last verified: May 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2009 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911729
Contacts
| Contact: Victoria M Divino, BA | 240-482-0034 ext 26 | victoria.divino@oxfordoutcomes.com |
| Contact: Emuella M Flood, BA | 240-482-0034 ext 29 | emuella.flood@oxfordoutcomes.com |
Locations
| United States, Maryland | |
| Oxford Outcomes- Nationwide Recruitment within the US | Recruiting |
| Bethesda, Maryland, United States, 20814 | |
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Emuella M Flood, BS | Oxford Outcomes |
More Information
No publications provided
| 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 1, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
|
paraganglioma pheochromocytoma |
Additional relevant MeSH terms:
|
Paraganglioma Pheochromocytoma Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 23, 2013