Pelvic Surgery for 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how certain features of gynecologic cancer affect recovery from major pelvic surgery, which involves removing and redirecting parts of the bladder and colon. Researchers will compare the effectiveness and safety of different surgical methods by gathering information through questionnaires, also known as Quality-of-Life Assessments. Women who have had gynecologic cancer and either have undergone or are about to undergo this type of surgery, and who can read and write in Spanish or English, might be suitable candidates for participation. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve surgical outcomes for future patients.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on understanding the long-term quality of life for women undergoing pelvic surgery for gynecologic cancer. Unlike traditional treatments that primarily focus on eliminating cancer, this trial emphasizes the patient's overall well-being and recovery experience post-surgery. By regularly administering detailed questionnaires, the trial aims to gather comprehensive insights into patients' emotional, social, and physical health over a decade. This approach could lead to more personalized care strategies that not only treat the cancer but also enhance the quality of life for survivors.

Who Is on the Research Team?

PT

Pamela T Soliman

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Quality-of-Life Assessment
  • Questionnaire Administration
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Observational (questionnaires)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+
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