Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502177
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2007-07-16
Brief Title:
Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 parentchild dyads on the Pediatric Quality of Life Cancer Module Version 30 PedsQL and the PedsQL 40 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 eg 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 andor 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 parentchild dyads on the Pediatric Quality of Life Cancer Module Version 30 PedsQL and the PedsQL 40 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 eg 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 andor 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 parentcaregiver questionnaires if heshe 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 parentcaregiver 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
ParentCaregiver Participant
Parent Participation
If you agree to take part in this study you will complete questionnaires about your perception of your childs quality of life If your child does not want to participate in this study you may still participate and complete the parentcaregiver questionnaire if you so choose If your child is too ill to participate in this study you will not be asked to complete hisher questionnaires on hisher behalf
The questionnaires will ask about your childs 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 parentcaregiver questionnaires if heshe 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 parentcaregiver 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
ParentCaregiver Participant
Parent Participation
If you agree to take part in this study you will complete questionnaires about your perception of your childs quality of life If your child does not want to participate in this study you may still participate and complete the parentcaregiver questionnaire if you so choose If your child is too ill to participate in this study you will not be asked to complete hisher questionnaires on hisher behalf
The questionnaires will ask about your childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None