NCT00597805

Quality of Life in Patients Undergoing Total Pelvic Exenteration

A Prospective Study of Quality of Life in Patients Undergoing Pelvic Exenteration

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn more about the personal experiences of patients who are treated with pelvic exenteration surgery. Pelvic exenteration is a surgical procedure in which the pelvic organs including the reproductive organs, bladder and/or rectum are removed. We would like to understand more about the physical, emotional, educational, and sexual needs of patients who are treated with this surgery. We will use what we learn from this study to help find better ways of preparing patients for this type of surgery. This will also allow us to be more helpful to patients' needs after surgery.

Detailed description

This protocol represents the first study to comprehensively evaluate QOL in a mixed population of male and female patients treated with total, anterior or posterior pelvic exenteration. This unique approach to QOL assessment which is both domain-centered and able to emphasize individual differences through the C-SHIP model has the potential to set the standard for evaluating QOL in patients who undergo extensive pelvic surgery. The longitudinal design of this study facilitates the documentation of patients'responsiveness to change. By analyzing participants' responses at intervals we will be able to document the redefinition of life goals which occurs as patients adapt to their new health status. The data and analysis completed in first three years of this study will be used to generate further hypotheses for future investigation.

Conditions

• Total Exenteration
• Anterior or Posterior Pelvic Exenteration
• Gynecologic Malignancies
• Colorectal Malignancies
• Urologic Malignancies

Interventions

Type	Name	Description
BEHAVIORAL	questionnaires/interviews	All patients who agree to participate will be interviewed for a baseline quality of life assessment prior to surgery. A brief in hospital interview will follow in the peri-operative period. In the ensuing months, patients will be interviewed at approximately 3, 6 and 12 months post-operatively (eg: 3 month interview will be done between 8-16 weeks and 6 month interview between 20-28 months post-operatively). Annual interviews in years two through five will be employed to determine areas for future study and solicit narrative on transition toward cancer survivorship.

Timeline

• Start date: 2005-01-01
• Primary completion: 2024-12-12
• Completion: 2024-12-12
• First posted: 2008-01-18
• Last updated: 2024-12-18

Locations

8 sites across 1 country: United States