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Quality of Life Questionnaire for Pediatric Patients Undergoing Peritoneal Perfusion
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, June 2009
First Received: July 16, 2007   Last Updated: June 22, 2009   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502177
  Purpose

The overall objective of this prospective study is to provide a descriptive analysis of the quality of life of pediatric cancer patients enrolled on M. D. Anderson Cancer Center Protocol 2005-0917, "A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Doses of Cisplatin for Children with Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease".

  • To examine the quality of life of pediatric patients who undergo CHPP 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 2005-0917.
  • To assess parent and child perception of the relative benefit of CHPP longitudinally. It is hypothesized that parents and children will perceive CHPP 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.
  • To determine whether quality of life following CHPP varies by demographic factors (e.g., age, culture), intraoperative cisplatin dose level, or subsequent treatment modalities. Some patients who undergo CHPP might subsequently be treated with other Phase I 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 2005-0917 at each intraoperative cisplatin dose level will be compared.

Condition Intervention
Peritoneal Neoplasms
Behavioral: Questionnaire

Study Type: Observational
Study Design: Case Control, 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: 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). ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 34
Study Start Date: June 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.
Behavioral: Questionnaire
Questionnaires taking a total of 10 minutes to complete.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up 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:

  • All participants must be English or Spanish speaking.
  • A child in Protocol 2005-0917, or one parent or adult non-parent primary caretaker of the child enrolled in Protocol 2005-0917.

Exclusion Criteria:

  • Pediatric patients not enrolled on Protocol 2005-0917 will be excluded from this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502177

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

Locations
United States, Texas
U.T.M.D. 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 U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Holly L. Green, BS/Physician Assistant )
Study ID Numbers: 2006-1106
Study First Received: July 16, 2007
Last Updated: June 22, 2009
ClinicalTrials.gov Identifier: NCT00502177     History of Changes
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

Study placed in the following topic categories:
Fever
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Peritoneal Diseases
Quality of Life
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Peritoneal Diseases
Peritoneal Neoplasms
Abdominal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009