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OpenTrials
Completed

NCT Number: NCT00788216

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Other names: Ultities Scores

Primary outcomes

  1. The development and validation of a comprehensive set of quality of life related utility scores for the treatment of cervical cancer.

    Time frame: lifetime

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
Nov 10, 2008
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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