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

Pheochromocytoma Clinical Trial

Official title:

Content Validation of the EORTC QLQ-C30 Version 3.0, and NIH Quality of Life and Symptoms Questionnaire for Pheochromocytoma and Paraganglioma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00911729
• Other study ID #: A1970
• Status: Terminated
• Phase: N/A
• First received: May 29, 2009
• Last updated: June 7, 2013
• Start date: April 2009

Study information

• Verified date: June 2013
• Source: Molecular Insight Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Paraganglioma
• Pheochromocytoma

Locations

Country	Name	City	State
United States	Oxford Outcomes- Nationwide Recruitment within the US	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Molecular Insight Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No