79 Participants Needed

Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer

PS
Overseen ByPamela Soliman
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The study investigates whether certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from surgery to remove the lower colon, rectum, and bladder, and create openings through which urine and stool are passed out of the body (pelvic exenteration). Comparing the types of surgery completed and procedures used may help researchers to determine which are most effective and safe in patients with a history of gynecologic cancer.

Research Team

PT

Pamela T Soliman

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology
Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy
Patients must be suitable candidates for surgery (in case of prospective collection)
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-Surgery Assessment

Patients complete questionnaires regarding feelings, abilities, depression, coping, social support, sexual function, and body image within 2 weeks before surgery.

2 weeks

Surgery

Patients undergo pelvic exenteration surgery.

Post-Surgery Follow-up

Patients complete questionnaires at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function, and body image.

10 years

Regular Follow-up

Patients are followed up every 3 months for the first 2 years, and then every 6 months for 3 years to monitor for complications and recurrence.

5 years

Treatment Details

Interventions

  • Quality-of-Life Assessment
  • Questionnaire Administration
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Observational (questionnaires)Experimental Treatment2 Interventions
RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of QOL questionnaires. PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.

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Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
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Recruited
1,813,000+
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