Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 1 - 18 |
| Updated: | 10/26/2018 |
| Start Date: | June 19, 2007 |
| End Date: | August 29, 2018 |
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.
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.
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.
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.
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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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