Quality of Life Questionnaire for Pediatric Patients Undergoing Peritoneal Perfusion
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Purpose
Objectives:
The overall objective of this prospective study is to provide a descriptive analysis of the quality of life of cancer patients enrolled on M. D. Anderson Cancer Center Protocol 2009-0528, "A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults with Desmoplastic Small Round Cell Tumor (DSRCT) and Other Non-carcinomas".
Specific Aim 1: To examine the quality of life of patients who undergo HIPEC longitudinally. It is hypothesized that physical health and functioning concerns, as reported by parent/child dyads on the Pediatric Quality of Life Cancer Module Version 3.0 (PedsQL) and the PedsQL 4.0 Generic Core Scales, will will remain stable or improve, following the surgical procedures and peritoneal perfusion described in Protocol 2009-0528.
Specific Aim 2: To assess parent and patient perception of the relative benefit of HIPEC longitudinally. It is hypothesized that parents and patients will perceive HIPEC to be beneficial across time, despite the temporary postoperative pain and discomfort that is associated with the procedure. This will be done by means of a non-validated question that is specific to the surgery.
Exploratory Aim: To determine whether quality of life following HIPEC varies by demographic factors (e.g., age, culture), intraoperative cisplatin dose level, or subsequent treatment modalities. Some patients who undergo HIPEC might subsequently be treated with other Phase II chemotherapy agents and/or palliative radiation, and comparing quality of life in these subgroups will be of value. Also the quality of life for groups of patients enrolled in Protocol 2009-0528 at each intraoperative cisplatin dose level will be compared.
| Condition | Intervention |
|---|---|
|
Peritoneal Neoplasms |
Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Quality of Life Questionnaire for Pediatric Patients Undergoing Continuous Hyperthermic Peritoneal Perfusion With Cisplatin |
- PedsQL 4.0 Generic Core Scale [ Time Frame: 6 Months ] [ Designated as safety issue: No ]The mean change in PedsQL 4.0 Generic Core Total Score over time (i.e., prior to operation vs. 6-months post-operation. The PedsQL 4.0 Generic Core will be administered to each child to ascertain their quality of life at the two time points).
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Quality of Life Questionnaire
Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.
|
Behavioral: Questionnaire
QOL Questionnaires taking a total of 10 minutes to complete.
Other Name: Survey
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.
Inclusion Criteria:
- All participants must be English or Spanish speaking.
- A patient enrolled on Protocol 2009-0528, and/or one parent or adult non-parent primary caretaker of the child enrolled on Protocol 2009-0528.
- Patients greater than or equal to 1 year.
Exclusion Criteria:
- Patients not enrolled on Protocol 2009-0528 will be excluded from this study.
- Patients less than 1 year.
Contacts and Locations| Contact: Holly L. Green, BS | 713-745-1818 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Holly L. Green, BS | |
| Principal Investigator: | Holly L. Green, BS | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00502177 History of Changes |
| Other Study ID Numbers: | 2006-1106 |
| Study First Received: | July 16, 2007 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Continuous Hyperthermic Peritoneal Perfusion Peritoneal Neoplasms Quality of Life |
Questionnaire Survey CHPP |
Additional relevant MeSH terms:
|
Neoplasms Peritoneal Neoplasms Abdominal Neoplasms Neoplasms by Site |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013