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Development & Validation of Utilities for Health States Relevant to Cervical Cancer Patients
This study is currently recruiting participants.
Verified by Duke University, November 2008
Sponsored by: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00788216
  Purpose

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 Intervention
Cervical Cancer
Other: Discussion & scoring of health states related to the treatment of cervical cancer

MedlinePlus related topics: Cancer Hysterectomy
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Development and Validation of A Comprehensive Instrument to Determine Utilities for Health States Relevant to Cervical Gynecologic Cancer Patients

Further study details as provided by Duke University:

Primary Outcome Measures:
  • The development and validation of a comprehensive set of quality if life related utility scores for the treatment of cervical cancer. [ Time Frame: lifetime ] [ Designated as safety issue: No ]

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. [ Time Frame: lifetime ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788216

Contacts
Contact: Elizabeth L Jewell, MD 919-684-3765 elizabeth.jewell@duke.edu
Contact: Debra M Davis, RN 919-684-2310 debra.m.davis@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Elizabeth L Jewell, MD     919-684-3765     elizabeth.jewell@duke.edu    
Contact: Debra M Davis, RN     919-684-2310     debra.m.davis@duke.edu    
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Elizabeth L Jewell, MD Duke University
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Duke University Medical Center ( Elizabeth Lin Jewell, MD )
Study ID Numbers: 00008129
Study First Received: November 6, 2008
Last Updated: November 10, 2008
ClinicalTrials.gov Identifier: NCT00788216  
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Radical hysterectomy
Whole pelvic radiation
Brachytherapy
Chemoradiation
Complications
Quality of Life

Study placed in the following topic categories:
Quality of Life

ClinicalTrials.gov processed this record on January 16, 2009