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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Women over the age of 18 without the diagnosis of cervical cancer. |
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| Cervical Cancer Patients | Women over the age of 18 with a history of cervical cancer treated with surgery or chemoradiation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| The development and validation of a comprehensive set of quality of life related utility scores for the treatment of cervical cancer. | lifetime |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Laura J Havrilesky, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |