Quality of Life Questionnaire for Pediatric Patients Undergoing Peritoneal Perfusion - Full Text View

Sponsor:	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:

MedlinePlus related topics: Cancer Fever

U.S. FDA Resources

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.

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Detailed Description:

Child Participant:

STUDY PARTICIPATION:

If you agree to take part in this study, you will complete questionnaires about your quality of life. If you do not want to participate in this study, your parent or caregiver may still participate and complete the parent/caregiver questionnaires if he/she chooses.

The questionnaires will ask about your experiences with pain, nausea, anxiety, worry, thinking and reasoning ability, physical appearance, communication, and your emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total, or longer if you need more time. You will also be asked about whether you worry about the surgery being effective.

If you are 4 years old or younger, your parent/caregiver will fill out the questionnaires for you.

If you are between 5 and 7 years old, the interviewer will go over the questionnaires with you.

If you are between 8 and 18 years old, you will fill out the questionnaires on your own.

The questionnaires will be filled out in the week before the surgery, 1 month after the surgery, and 6 months after the surgery.

You will only come in if you already have a scheduled visit because of the study you are presently on. However, if you are no longer on that study then you will still be asked to complete the questionnaires at the 1- and 6-month time points. This can be done by telephone or at other regularly scheduled visits at those time points.

Length of Study:

Your participation in this study will be over after you finish the 6-month questionnaires.

Parent/Caregiver Participant:

If you agree to take part in this study, you will complete questionnaires about your perception of your child's quality of life. If your child does not want to participate in this study, you may still participate and complete the parent/caregiver questionnaire, if you so choose. If your child is too ill to participate in this study, you will not be asked to complete his/her questionnaires on his/her behalf.

The questionnaires will ask about your child's quality of life regarding pain, nausea, anxiety, worry, cognitive functioning (thinking and reasoning), physical appearance, communication, and his or her emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total.

You will also be asked a surgery-specific question about whether your child worries about the effectiveness of the surgery.

LENGTH OF STUDY:

Your participation in this study will be over after completion of the 6-month questionnaires.

This is an investigational study. Up to 17 parents and 17 children will participate in this study. All will be enrolled at M. D. Anderson.

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:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

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

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 November 27, 2009