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

July 16, 2007
June 22, 2009
June 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
The goal of this research study is to evaluate quality of life before and after the abdominal surgery and continuous hyperthermic peritoneal perfusion with cisplatin. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00502177 on ClinicalTrials.gov Archive Site
 
 
 
Quality of Life Questionnaire for Pediatric Patients Undergoing Peritoneal Perfusion
Quality of Life Questionnaire for Pediatric Patients Undergoing Continuous Hyperthermic Peritoneal Perfusion With Cisplatin

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.

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.

 
Observational
Case Control, Prospective
Peritoneal Neoplasms
Behavioral: Questionnaire
Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
34
 
December 2009   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
Yes
Contact: Holly L. Green, BS 713-745-1818
United States
 
NCT00502177
Holly L. Green, BS/Physician Assistant, U.T.M.D. Anderson Cancer Center
2006-1106
M.D. Anderson Cancer Center
 
Principal Investigator: Holly L. Green, BS U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP