Simple Versus Radical Hysterectomy for Stage I Cervical Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00506376
First received: July 20, 2007
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention
Cervical Cancer
Behavioral: Interview

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Preference Assessment [ Time Frame: Baseline + Interview ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: January 2003
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506376

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Charlotte C. Sun, DrPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00506376     History of Changes
Other Study ID Numbers: ID02-741
Study First Received: July 20, 2007
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 10, 2014