Pelvic Exenteration for Gynecologic Malignancy
Conditions
Cervical Cancer - Endometrial Cancer - Vaginal Cancer - Vulvar Cancer - Gynecologic Cancer
Conditions: official terms
Uterine Cervical Neoplasms - Vaginal Neoplasms - Vulvar Neoplasms
Conditions: Keywords
Cervical Cancer, Vaginal Cancer, Endometrial Cancer, Cervix, Endometrial, Pelvic Exenteration, Pelvic Exenteration Surgery, Questionnaire, Gynecologic Cancer, Vagina, Vulva, Gynecologic Malignancy
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Questionnaires
Type: Behavioral
Overall Status
Recruiting
Summary
The goal of this study is to learn if certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from pelvic exenteration surgery. Researchers will compare the types of surgery completed and procedures used to find out which are most effective and safe. Researchers will also study how this surgery affects your quality of life.
Detailed Description
Prospective Study Procedures:

Study Procedures:

If you agree to take part in this study, you will be asked to complete a series of questionnaires at specific times. The questionnaires ask questions about how you feel, what you are able to do, depression, coping, social support, sexual function, and your body image. There are 11 questionnaires in total, but not all will be filled out on each day.

You will complete questionnaires at the following times:

- You will complete 7 questionnaires before surgery. They will take about 40 minutes to complete.

- You will complete 4 questionnaires about 4-6 weeks after surgery. They will take about 25 minutes to complete.

- You will complete 8 questionnaires about 6 months after surgery. They will take about 45 minutes to complete.

- You will complete 8 questionnaires at 1, 2, 5 and 10 years after surgery. They will take about 50 minutes to complete each time.

- You will complete 2 questionnaires at 3 and 4 years after surgery. They will take about 10 minutes to complete each time.

- If you have cervical cancer, you will be asked to complete 1 additional questionnaire during each of these visits.

If you are being followed at MD Anderson, you can fill out the questionnaires at your follow-up visits. If you do not have time to fill out the questionnaires during your visits or you are being followed at another hospital you may return the questionnaire by mail in a pre-stamped envelope we will send to you with the questionnaires. These questionnaires may also be answered over the phone.

If you complete the surgery, information on complications and/or problems that you may experience in the first 60 days after surgery, and how you are doing after you have your standard follow up visits every 3 months for the first 2 years and then every 6 months for the next 3 years will be collected from your medical records.

Length of Study:

If you are unable to have surgery, you will be taken off study. If you are able to complete the surgery, you will remain on study for up to 10 years after surgery.

This is an investigational study.

Up to 200 patients will take part in this study. Up to 199 will be enrolled at MD Anderson.

Retrospective Study Procedures:

Study Procedures:

If you agree to take part in this study, you will be asked to complete a series of questionnaires. There are 11 questionnaires in total, the type and number of questionnaires depend on how long after surgery you enroll in this study and if you have cervical or other gynecological cancer. The questionnaires ask questions about how you feel, what you are able to do, depression, coping, social support, sexual function, and your body image.

If you are being followed at MD Anderson, you can fill out the questionnaires at your follow-up visits. If you do not have time to fill out the questionnaires during your visits or you are being followed at another hospital you may return the questionnaire by mail in a pre-stamped envelope we will send to you with the questionnaires. These questionnaires may also be answered over the phone.

Information on complications and/or problems that you may experience in the first 60 days after surgery, how you are doing after you have your standard follow up visits every 3 months for the first 2 years and then every 6 months for the next 3 years will be collected from your medical records.

Length of Study:

You will remain on study for up to 10 years after your surgery.

This is an investigational study.

Up to 200 patients will take part in this study. Up to 199 will be enrolled at MD Anderson.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology.

2. Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy.

3. Patients must be suitable candidates fo surgery (in case of prospective collection).

4. Patients who have signed an approved Informed Consent.

5. Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease.

6. Females older than 18 years.

7. Women must be able to read and write in either Spanish or English.

Exclusion Criteria:

1. Patients with contraindications to surgery.

2. Patients unwilling or unable to complete self-administered questionnaires.

3. Patients who do not read or speak English or Spanish.
Locations
St. Luke's Episcopal Hospital
Houston, Texas, United States
Status: Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
September 2008
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page