Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-31 @ 3:11 AM
Study NCT ID:
NCT00675467
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2008-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care and Symptom Management for the Pediatric Oncology Patient
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Palliative Care and Symptom Management for the Pediatric Oncology Patient
Status:
COMPLETED
Status Verified Date:
2016-04
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:
The goal of this study is to learn about the communication, decision-making, symptom management, emotional adjustment, and spiritual needs of parents and pediatric patients treated at the Children's Cancer Hospital at M. D. Anderson (MCACC).
Primary Objectives:
1. Determine the palliative care service needs of pediatric cancer patients and their parents, including communication, decision-making, symptom management, emotional and spiritual support when receiving treatment for early cancer, treatment for advanced disease, and treatment in the end-of-life period.
2. Identify intra-group differences in the categories listed in Objective 1 for pediatric cancer patients receiving treatment (a) for early cancer, (b) for advanced disease, and (c) at end-of-life.
Secondary Objectives:
1\. Inform the development of a Pediatric Palliative Care Program at the Children's Cancer Hospital at The University of Texas M. D. Anderson Cancer Center (MCACC or MDACC) based on identified needs as determined by primary study aims 1 and 2.
Primary Objectives:
1. Determine the palliative care service needs of pediatric cancer patients and their parents, including communication, decision-making, symptom management, emotional and spiritual support when receiving treatment for early cancer, treatment for advanced disease, and treatment in the end-of-life period.
2. Identify intra-group differences in the categories listed in Objective 1 for pediatric cancer patients receiving treatment (a) for early cancer, (b) for advanced disease, and (c) at end-of-life.
Secondary Objectives:
1\. Inform the development of a Pediatric Palliative Care Program at the Children's Cancer Hospital at The University of Texas M. D. Anderson Cancer Center (MCACC or MDACC) based on identified needs as determined by primary study aims 1 and 2.
Detailed Description:
PARENT:
The Focus Group:
If you agree to take part in this study, you will attend a 1 1/2 hour group session with 3-9 other caregivers. The group will be led by a group leader and an assistant. The group leader will ask questions to the group about communication, decision-making, symptom management, emotional adjustment, and spirituality experiences and needs during your child's treatment. If you have a child who is also taking part in this study, you will meet separately from your child.
At the time of your arrival and before the beginning of the focus group session, you will be asked to complete a questionnaire. You will be asked about you and your child's age, sex, where you live, your religion (if any), your ethnicity and race, and if there are other children in the family. You will be asked about when you found out your child had cancer, the type of cancer, and when the cancer got worse or came back (if applicable). You will be asked whether others have shared parenting responsibilities, your education level, and if you work and what type of work you do. The questionnaire will take about 5 minutes to complete.
Audiotapes/Transcripts:
The assistant will take notes and the session will be recorded on an audiotape. All audiotapes will be stored in locked cabinets maintained by the study chair. The audiotapes will be destroyed once the study and analyses are complete.
The audiotape will be recorded onto paper "transcripts". The completed focus group transcriptions will be placed in a database secured with a password and identification protected. Transcribed results will have all identifiable markers removed and kept in the investigators' locked files. Only the researchers will be able to view the transcriptions.
Length of Study:
Your participation on this study is complete once you finish the group meeting.
PEDIATRIC PARTICIPANT:
The Focus Group:
If you agree to take part in this study, you will go to a 1 1/2 hour group session with 3-9 other patients. The group will be led by a group leader and an assistant. The group leader will ask questions to the group about who you talk with about the disease, how you make a decision, how you manage any symptoms you may have, how you are feeling about the disease, and how religion has helped you during your treatment. If your parent is also taking part in this study, you will meet separately from your parent.
At the time of your arrival and before the beginning of the focus group session, your parent will be asked to complete a questionnaire. Your parent will be asked about their age and sex, your age and sex, where you live, your religion (if any), your ethnicity and race, and if there are other children in the family. Your parent will be asked when they found out you had cancer, the type of cancer, and when the cancer got worse or came back (if applicable). Your parent will be asked whether others have shared parenting responsibilities, their education level, and if they work and about the type of work they do. The questionnaire will take about 5 minutes to complete.
Audiotapes/Transcripts:
The assistant will take notes and the session will be recorded on an audiotape. All audiotapes will be stored in locked cabinets taken care of by the study chair. The audiotapes will be destroyed once the study is over and the researchers have finished looking at the information.
The audiotape will be recorded onto paper "transcripts". The completed focus group transcriptions will be placed in a database secured with a password and identification protected. Any personal information about you will be removed from these papers and the papers will be kept in the investigators' locked files. Only the researchers will be able to view the transcriptions.
Length of Study:
Your participation on this study is over once you complete the focus group.
The Focus Group:
If you agree to take part in this study, you will attend a 1 1/2 hour group session with 3-9 other caregivers. The group will be led by a group leader and an assistant. The group leader will ask questions to the group about communication, decision-making, symptom management, emotional adjustment, and spirituality experiences and needs during your child's treatment. If you have a child who is also taking part in this study, you will meet separately from your child.
At the time of your arrival and before the beginning of the focus group session, you will be asked to complete a questionnaire. You will be asked about you and your child's age, sex, where you live, your religion (if any), your ethnicity and race, and if there are other children in the family. You will be asked about when you found out your child had cancer, the type of cancer, and when the cancer got worse or came back (if applicable). You will be asked whether others have shared parenting responsibilities, your education level, and if you work and what type of work you do. The questionnaire will take about 5 minutes to complete.
Audiotapes/Transcripts:
The assistant will take notes and the session will be recorded on an audiotape. All audiotapes will be stored in locked cabinets maintained by the study chair. The audiotapes will be destroyed once the study and analyses are complete.
The audiotape will be recorded onto paper "transcripts". The completed focus group transcriptions will be placed in a database secured with a password and identification protected. Transcribed results will have all identifiable markers removed and kept in the investigators' locked files. Only the researchers will be able to view the transcriptions.
Length of Study:
Your participation on this study is complete once you finish the group meeting.
PEDIATRIC PARTICIPANT:
The Focus Group:
If you agree to take part in this study, you will go to a 1 1/2 hour group session with 3-9 other patients. The group will be led by a group leader and an assistant. The group leader will ask questions to the group about who you talk with about the disease, how you make a decision, how you manage any symptoms you may have, how you are feeling about the disease, and how religion has helped you during your treatment. If your parent is also taking part in this study, you will meet separately from your parent.
At the time of your arrival and before the beginning of the focus group session, your parent will be asked to complete a questionnaire. Your parent will be asked about their age and sex, your age and sex, where you live, your religion (if any), your ethnicity and race, and if there are other children in the family. Your parent will be asked when they found out you had cancer, the type of cancer, and when the cancer got worse or came back (if applicable). Your parent will be asked whether others have shared parenting responsibilities, their education level, and if they work and about the type of work they do. The questionnaire will take about 5 minutes to complete.
Audiotapes/Transcripts:
The assistant will take notes and the session will be recorded on an audiotape. All audiotapes will be stored in locked cabinets taken care of by the study chair. The audiotapes will be destroyed once the study is over and the researchers have finished looking at the information.
The audiotape will be recorded onto paper "transcripts". The completed focus group transcriptions will be placed in a database secured with a password and identification protected. Any personal information about you will be removed from these papers and the papers will be kept in the investigators' locked files. Only the researchers will be able to view the transcriptions.
Length of Study:
Your participation on this study is over once you complete the focus group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: