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

This study is currently recruiting participants.

Verified by Molecular Insight Pharmaceuticals, Inc., May 2009

First Received: May 29, 2009 Last Updated: June 1, 2009 History of Changes

Sponsor:	Molecular Insight Pharmaceuticals, Inc.
Information provided by:	Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00911729

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:	Case-Only, 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:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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:	Molecular Insight Pharmaceuticals, Inc ( Meredith Frank-Molnia )
Study ID Numbers:	A1970
Study First Received:	May 29, 2009
Last Updated:	June 1, 2009
ClinicalTrials.gov Identifier:	NCT00911729 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Molecular Insight Pharmaceuticals, Inc.:

paraganglioma
pheochromocytoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Paraganglioma
Neoplasms by Histologic Type

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Pheochromocytoma
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on November 20, 2009