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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788216
• Other study ID #: Pro00008129
• Status: Completed
• Phase: N/A
• First received: November 6, 2008
• Last updated: July 11, 2013
• Start date: September 2008
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The development and validation of a comprehensive set of quality of life related utility scores for the treatment of cervical cancer.		lifetime	No
Secondary	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	No

External Links

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