Quality of Life Questionnaire for Pediatric Patients Undergoing Peritoneal Perfusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00502177
First received: July 16, 2007
Last updated: February 20, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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
Study Population

Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.

Criteria

Inclusion Criteria:

  1. All participants must be English or Spanish speaking.
  2. 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.
  3. Patients greater than or equal to 1 year.

Exclusion Criteria:

  1. Patients not enrolled on Protocol 2009-0528 will be excluded from this study.
  2. Patients less than 1 year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502177

Contacts
Contact: Holly L. Green, BS 713-745-1818

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Holly L. Green, BS         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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: February 20, 2014
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 July 22, 2014