Simple Versus Radical Hysterectomy for Stage I Cervical Cancer

February 25, 2016 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants at high-risk for cervical cancer and those already diagnosed with cervical cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical Treatment Preferences
Assessment of patient's feelings toward risks associated with surgical treatment of cervical cancer.
Behavioral: Interview
Interview that will take about 20 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preference Assessment
Time Frame: Baseline + Interview
Baseline + Interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Charlotte C. Sun, DrPH, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 20, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID02-741

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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