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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00788216

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Other: Discussion & scoring of health states related to the treatment of cervical cancer

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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Healthy Volunteers Women over the age of 18 without the diagnosis of cervical cancer.	Other: Discussion & 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. Other Names: Ultities Scores
Cervical Cancer Patients Women over the age of 18 with a history of cervical cancer treated with surgery or chemoradiation.	Other: Discussion & 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. Other Names: Ultities Scores

Arm

Intervention/Treatment

Healthy Volunteers

Women over the age of 18 without the diagnosis of cervical cancer.

Other: Discussion & 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.

Other Names:

Ultities Scores

Cervical Cancer Patients

Women over the age of 18 with a history of cervical cancer treated with surgery or chemoradiation.

Other: Discussion & 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.

Other Names:

Ultities Scores

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.