Simple Versus Radical Hysterectomy for Stage I Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506376
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : February 26, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Cervical Cancer Behavioral: Interview

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
Actual Enrollment : 85 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : January 2003
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Preference Assessment [ Time Frame: Baseline + Interview ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants at high-risk for cervical cancer and those already diagnosed with cervical cancer.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00506376

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Charlotte C. Sun, DrPH M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00506376     History of Changes
Other Study ID Numbers: ID02-741
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016

Keywords provided by M.D. Anderson Cancer Center:
Cervical Cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female