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Development and Validation of A Comprehensive Instrument to Determine Utilities for Health States Relevant to Cervical Gynecologic Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

Development and Validation of A Comprehensive Instrument to Determine Utilities for Health States Relevant to Cervical Gynecologic Cancer Patients


Subjects will valuate cervical cancer-related health states using the visual analog score
(VAS) and TTO (TTO) methods. The subject will be asked to read a pertinent health state
description and listen while it is read aloud. She will first be asked to place the state on
a continuum (VAS) from zero to 100, with 100 presenting perfect health and zero presenting
death. The TTO interview will then be administered. The subject will be asked to assume a
remaining life expectancy of 30 years, and to choose between 30 years in the health state
described or 29 years in a state of perfect health. The utility of the health state, a
number between zero and one, is calculated as the minimum number of years the patient would
accept divided by 30. Each subject will be asked to review and valuate 20 health states over
the course of 60-90 minutes.


Inclusion Criteria:



- Any member of public over age of 18 and without the diagnosis of cervical cancer can
participate in this study.

- Patients over the age of 18 with the diagnosis of cervical cancer are eligible to
participate in this study.

Exclusion Criteria:

- Any member of public under the age of 18 or with a prior diagnosis of cervical cancer
is excluded from this study.

- Any cervical cancer patient younger than 18 is excluded from this study.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

The development and validation of a comprehensive set of quality of life related utility scores for the treatment of cervical cancer.

Outcome Time Frame:

lifetime

Safety Issue:

No

Principal Investigator

Laura J Havrilesky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00008129

NCT ID:

NCT00788216

Start Date:

September 2008

Completion Date:

June 2013

Related Keywords:

  • Cervical Cancer
  • Radical hysterectomy
  • Whole pelvic radiation
  • Brachytherapy
  • Chemoradiation
  • Complications
  • Quality of Life
  • Uterine Cervical Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710