Simple Versus Radical Hysterectomy for Stage I Cervical Cancer
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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 |
- Preference Assessment [ Time Frame: Baseline + Interview ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | January 2003 |
| Estimated Primary Completion Date: | January 2015 (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 |
Participants at high-risk for cervical cancer and those already diagnosed with cervical cancer.
Inclusion Criteria:
- Women who are at least 18 years of age.
- Women who speak English
- 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:
- Women who are not 18 years of age.
- Women who are non-English speakers.
- Women with a diagnosis of any type of cancer other than cervical cancer.
- Women who are currently pregnant.
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| 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, 2013 |
| 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 May 22, 2013