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Quality of Life Questionnaire for Pediatric Patients Undergoing Continuous Hyperthermic Peritoneal Perfusion With Cisplatin


N/A
1 Year
18 Years
Open (Enrolling)
Both
Peritoneal Neoplasms

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Trial Information

Quality of Life Questionnaire for Pediatric Patients Undergoing Continuous Hyperthermic Peritoneal Perfusion With Cisplatin


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, 3 months 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, 3 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:

Parent Participation:

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 20 parents and 20 children will participate in this
study. All will be enrolled at MD Anderson.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

PedsQL 4.0 Generic Core Scale

Outcome Description:

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).

Outcome Time Frame:

6 Months

Safety Issue:

No

Principal Investigator

Holly L. Green, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-1106

NCT ID:

NCT00502177

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Peritoneal Neoplasms
  • Continuous Hyperthermic Peritoneal Perfusion
  • Peritoneal Neoplasms
  • Quality of Life
  • Questionnaire
  • Survey
  • CHPP
  • Neoplasms
  • Peritoneal Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030