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Quality of Life in Patients Undergoing Total Pelvic Exenteration

This study is currently recruiting participants.
Verified October 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597805
First Posted: January 18, 2008
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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

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 ]

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 ]

Estimated Enrollment: 136
Actual Study Start Date: January 2005
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597805


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

Locations
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Dennis Chi, MD    212-639-5016      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Dennis Chi, MD    212-639-5016      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Dennis Chi, MD    212-639-5016      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Dennis Chi, MD    212-639-5016      
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         
Memorial Sloan Kettering @ Rockville Recruiting
Rockville Centre, New York, United States, 11570
Contact: Dennis Chi, MD    212-639-5016      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Dennis Chi, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00597805     History of Changes
Other Study ID Numbers: 05-001
First Submitted: January 9, 2008
First Posted: January 18, 2008
Last Update Posted: October 23, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neoplasms