Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin
Condition: Peritoneal Neoplasms
MeSH terms: Peritoneal Neoplasms; Hyperthermia; Fever
Study type: Observational

Summary: 
      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.
    

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, 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.

      This is an investigational study. Up to 20 parents and 20 children will participate in this
      study. All will be enrolled at M. D. Anderson.

      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.
    

Intervention name(s): Questionnaire
Intervention type(s): Behavioral
Intervention description(s): QOL Questionnaires taking a total of 10 minutes to complete.
Other intervention name(s): Survey
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their
        parents/caregivers.
      
Keywords: Continuous Hyperthermic Peritoneal Perfusion; Peritoneal Neoplasms; Quality of Life; Questionnaire; Survey; CHPP