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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00788216
First received: November 6, 2008
Last updated: July 11, 2013
Last verified: July 2013
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Development and Validation of A Comprehensive Instrument to Determine Utilities for Health States Relevant to Cervical Gynecologic Cancer Patients

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • The development and validation of a comprehensive set of quality of 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 ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: June 2013
Primary Completion Date: September 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.
Other Name: 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 Name: Ultities Scores

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Laura J Havrilesky, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00788216     History of Changes
Other Study ID Numbers: Pro00008129
Study First Received: November 6, 2008
Last Updated: July 11, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 20, 2014