Quality of Life in Patients Undergoing Total Pelvic Exenteration

Gynecologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00597805
• Other study ID #: 05-001
• Status: Active, not recruiting
• Start date: January 2005
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients (male and female) who are scheduled to undergo total, anterior or posterior pelvic exenteration for pelvic malignancies arising in gynecologic, colorectal or urologic organs are eligible for participation in the study. Anterior or posterior pelvic exenteration must involve formation of a permanent ostomy (urostomy or colostomy).

• Participants must be able to speak and read English proficiently.

• Participants must be able to provide written informed consent.

• Patients must be 18 years of age or older to enroll.

Exclusion Criteria:

• Subjects may be excluded or withdrawn from the study based on the following criteria.

• Development of a cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent

• Inability to speak or read in English.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the extent of physical and psychological stress, and overall quality of life in patients undergoing total, anterior or posterior pelvic exenteration.		conclusion of study
Secondary	To determine how patients ratings of the specific QOL domains predict response to surgery, (ie; QOL, level of stress, function and symptoms).		conclusion of study

External Links

•   Memorial Sloan Kettering Cancer Center