NCT00911729

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

First QC Date

May 29, 2009

Last Update Submit

June 7, 2013

Conditions

PheochromocytomaParaganglioma

Keywords

paragangliomapheochromocytoma

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Outcomes- Nationwide Recruitment within the US

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

PheochromocytomaParaganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Emuella M Flood, BS

    Oxford Outcomes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 2, 2009

Study Start

April 1, 2009

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

US(1)