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

NCT00788216 | Completed

• 1 other identifier: Pro00008129
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

Radical hysterectomy; Whole pelvic radiation; Brachytherapy; Chemoradiation; Complications; Quality of Life

Outcome Measures

Primary Outcomes (1)

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

  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.

  lifetime

Study Arms (2)

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

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

Interventions

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.

Also known as: Ultities Scores

Cervical Cancer Patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura J Havrilesky, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 10, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: June 1, 2013
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

US (1)