Quality of Life in Patients Undergoing Total Pelvic Exenteration



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:January 2005
End Date:January 2020
Contact:Dennis Chi, MD
Phone:212-639-5016

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

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.

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- Subjects may be excluded or withdrawn from the study based on the following criteria.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.
We found this trial at
9
sites
480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-5016
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Phone: 813-745-4673
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-5016
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Basking Ridge, NJ
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
Phone: 212-639-5016
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Commack, NY
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Harrison, New York
Phone: 212-639-5016
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Harrison, NY
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-5016
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Montvale, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Dennis Chi, MD
Phone: 212-639-5016
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1000 North Village Avenue
Rockville Centre, New York 11570
Phone: 212-639-5016
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Rockville Centre, NY
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Uniondale, New York 11553
Phone: 212-639-5016
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Uniondale, NY
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