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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
  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:


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
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

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 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
paraganglioma
pheochromocytoma

Additional relevant MeSH terms:
Paraganglioma
Pheochromocytoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on November 25, 2014