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

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Duke University

Status

Completed

Conditions

Cervical Cancer

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT00788216
Pro00008129

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Healthy Volunteers
Description:
Women over the age of 18 without the diagnosis of cervical cancer.
Treatment:
Other: Discussion & scoring of health states related to the treatment of cervical cancer
Cervical Cancer Patients
Description:
Women over the age of 18 with a history of cervical cancer treated with surgery or chemoradiation.
Treatment:
Other: Discussion & scoring of health states related to the treatment of cervical cancer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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