Simple Versus Radical Hysterectomy for Stage I Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Simple Versus Radical Hysterectomy for Stage I Cervical Cancer: Preferences of Women at High-Risk for Developing Cervix Cancer vs. Women Diagnosed With Cervix Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506376
• Other study ID #: ID02-741
• Status: Completed
• Phase: N/A
• First received: July 20, 2007
• Last updated: February 25, 2016
• Start date: January 2003
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to assess the preferences (values and utilities) of women for complications and recurrences associated with the surgical treatment of cervical cancer. A secondary objective of this study is to compare the preferences of women at high-risk for developing cervix cancer with the preferences of women who have already been diagnosed with cervix cancer.

Description:

You will be asked to undergo a face to face interview. During the interview, you will be asked questions about your values and feelings about your health status. You will be shown a "feeling thermometer" and asked to rate how your health condition makes you feel. You will also be asked to rate how some of the risks of treatment of cervix cancer make you feel. You will be shown a "chance board" and asked to consider some of the possible outcomes of the disease and possible risks associated with the treatment of cervix cancer. You will be asked to consider the likelihood of achieving certain outcomes and of developing certain side effects due to the disease and/or treatment. The interview will take place in a private room in the clinic and should take around 20 minutes to complete.

This is an investigational study. As many as 96 women will participate in this study. Up to 48 women who are at high risk of developing cervix cancer and up to 48 women who have been diagnosed with cervix cancer will participate. All will be enrolled at M. D. Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women who are at least 18 years of age.

2. Women who speak English

3. Women presenting to the Colposcopy Clinic in the Gynecologic Oncology Clinic at M.D. Anderson Cancer Center OR women with an established diagnosis of either Stage IA2 or IB1 cervix cancer treated with radical hysterectomy 3-24 months prior to presenting to the Gynecologic Oncology

Exclusion Criteria:

1. Women who are not 18 years of age.

2. Women who are non-English speakers.

3. Women with a diagnosis of any type of cancer other than cervical cancer.

4. Women who are currently pregnant.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Interview
Interview that will take about 20 minutes to complete.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference Assessment		Baseline + Interview	No

External Links

•   University of Texas MD Anderson Cancer Center Website