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

NCT ID: NCT00788216

Last Updated: 2013-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2013-06-30

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.

Conditions

Cervical Cancer

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers

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

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

Intervention Type: OTHER

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

Cervical Cancer Patients

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

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Ultities Scores

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura J Havrilesky, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00008129

Identifier Type: -

Identifier Source: org_study_id