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Spots Global Cancer Trial Database for Development & Validation of Utilities for Health States Relevant to Cervical Cancer Patients

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Trial Identification

Brief Title: Development & Validation of Utilities for Health States Relevant to Cervical Cancer Patients

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

Study ID: NCT00788216

Conditions

Cervical Cancer

Study Description

Brief Summary: Purposes of this study: 1) To define comprehensive set of descriptive health states related to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation, brachytherapy, chemoradiation) 2) To define set of descriptive health states related to adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain, enteritis, fistula formation) \& 3) To derive, using a validated method, a set of QoL related utility scores corresponding to these health states.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Duke University Medical Center, Durham, North Carolina, United States

Contact Details

Name: Laura J Havrilesky, MD

Affiliation: Duke University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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