Quality of Life in Patients Undergoing Total Pelvic Exenteration

This study is currently recruiting participants.
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00597805
First received: January 9, 2008
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Total Exenteration,
Anterior or Posterior Pelvic Exenteration
Gynecologic Malignancies
Colorectal Malignancies
Urologic Malignancies
Behavioral: questionnaires/interviews

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Quality of Life in Patients Undergoing Pelvic Exenteration

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To characterize the extent of physical and psychological stress, and overall quality of life in patients undergoing total, anterior or posterior pelvic exenteration. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine how patients ratings of the specific QOL domains predict response to surgery, (ie; QOL, level of stress, function and symptoms). [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: January 2005
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients scheduled for a total, anterior or posterior pelvic exenteration
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MSKCC's Clinics and Moffitt Cancer Center, Tampa, Florida

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597805

Contacts
Contact: Dennis Chi, MD 212-639-5016
Contact: Bernard Bochner, MD 646-422-4387

Locations
United States, Florida
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Robert Wenham, MD         
Principal Investigator: Robert Wenham, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dennis Chi, MD    212-639-5016      
Contact: Bernard Bochner, MD    646-422-4387      
Principal Investigator: Dennis Chi, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Dennis Chi, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00597805     History of Changes
Other Study ID Numbers: 05-001
Study First Received: January 9, 2008
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014