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

Completed

• Conditions: Cervical Cancer
• Interventions: Other: Discussion & scoring of health states related to the treatment of cervical cancer

• Registration Number: NCT00788216
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Primary Completion: 2009-09
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-11
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Discussion & scoring of health states related to the treatment of cervical cancer	Women over the age of 18 without the diagnosis of cervical cancer.
Cervical Cancer Patients	Discussion & scoring of health states related to the treatment of cervical cancer	Women over the age of 18 with a history of cervical cancer treated with surgery or chemoradiation.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To incorporate these utility scores into a previous decision model which will allow for outcomes, costs, and quality of life to be analyzed in the treatment of cervical cancer patients.	lifetime

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States