Quality of Life in Patients Undergoing Total Pelvic Exenteration
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 2014 |
| Estimated Primary Completion Date: | January 2014 (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 |
MSKCC's Clinics and Moffitt Cancer Center, Tampa, Florida
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| Contact: Dennis Chi, MD | 212-639-5016 | |
| Contact: Bernard Bochner, MD | 646-422-4387 |
| 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 | |
| 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: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013