A Prospective Study of Quality of Life in Patients Undergoing Pelvic Exenteration
18 Years
N/A
Both
Total Exenteration,, Anterior or Posterior Pelvic Exenteration, Gynecologic Malignancies, Colorectal Malignancies, Urologic Malignancies
Trial Information
A Prospective Study of Quality of Life in Patients Undergoing Pelvic Exenteration
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.
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- Subjects may be excluded or withdrawn from the study based on the following criteria.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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
To characterize the extent of physical and psychological stress, and overall quality of life in patients undergoing total, anterior or posterior pelvic exenteration.
Outcome Time Frame:
conclusion of study
Safety Issue:
No
Principal Investigator
Dennis Chi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
05-001
NCT ID:
NCT00597805
Start Date:
January 2005
Completion Date:
January 2014
Related Keywords:
- Total Exenteration,
- Anterior or Posterior Pelvic Exenteration
- Gynecologic Malignancies
- Colorectal Malignancies
- Urologic Malignancies
- Neoplasms
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Moffitt Cancer Center | Tampa, Florida 33612 |
