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Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Endometrial Cancer, Vaginal Cancer, Vulvar Cancer, Gynecologic Cancer

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Trial Information

Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy


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 190 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 190 will be enrolled at MD Anderson.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Types of Complications Experienced by Women Undergoing Pelvic Exenteration

Outcome Time Frame:

4 Years

Safety Issue:

No

Principal Investigator

Pamela Soliman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0095

NCT ID:

NCT00791635

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Vaginal Cancer
  • Vulvar Cancer
  • Gynecologic Cancer
  • Cervical Cancer
  • Vaginal Cancer
  • Endometrial Cancer
  • Cervix
  • Endometrial
  • Pelvic Exenteration
  • Pelvic Exenteration Surgery
  • Questionnaire
  • Gynecologic Cancer
  • Vagina
  • Vulva
  • Gynecologic Malignancy
  • Neoplasms
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Adenoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
St. Luke's Episcopal HospitalHouston, Texas  77030