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

Terminated

• Conditions: Paraganglioma; Pheochromocytoma

• Registration Number: NCT00911729
• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-07
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Single Visit

Trial Locations

Locations (1)

Oxford Outcomes- Nationwide Recruitment within the US; 🇺🇸 Bethesda, Maryland, United States