Clinical trial NCT00788216: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Radical hysterectomy
Whole pelvic radiation
Brachytherapy
Chemoradiation
Complications
Quality of Life
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-11-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of the Public- Members of the public are considered the standard group to assign utilities for health-economic purposes. Forty-five members of the public, without a diagnosis of cervical cancer, will be recruited.

Cervical Cancer Patients- Fifteen patients, with a diagnosis of cervical cancer (either currently being treated or previously treated).

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 criteria: 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.

Primary outcomes:
measure: The development and validation of a comprehensive set of quality of life related utility scores for the treatment of cervical cancer.
timeFrame: lifetime
Secondary outcomes:
measure: 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.
timeFrame: lifetime
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Laura J Havrilesky, MD
role: PRINCIPAL_INVESTIGATOR
References: