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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00788216
Enrollment
60
Registered
2008-11-10
Start date
2008-09-30
Completion date
2013-06-30
Last updated
2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Radical hysterectomy, Whole pelvic radiation, Brachytherapy, Chemoradiation, Complications, Quality of Life

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.

Interventions

OTHERDiscussion & scoring of health states related to the treatment of cervical cancer

Subjects will be interviewed using the visual analog score and time trade off methods.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026