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

This study has been terminated.

Sponsor:

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

History of Changes

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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	24
Study Start Date:	April 2009

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority:	United States: Institutional Review Board

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 23, 2016

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