Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477256
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2007-05-22
Brief Title:
School Reintegration Outcomes in Pediatric Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Psychosocial Predictors of Child Adjustment and School Reintegration Outcome in a Pediatric Cancer Population
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Primary Objectives
1 To examine illness-related factors ie severity of illness quality of life rating as predictors or correlates of child adjustment to pediatric cancer
2 To examine illness-related factors ie severity of illness quality of life rating as predictors of school reintegration ie school attendance in children with pediatric cancer
3 To examine a within-parent factor ie parental stress as a predictor or correlate of child adjustment to pediatric cancer
4 To examine a within-parent factor ie parental stress as a predictor or correlate of school reintegration ie school attendance
Secondary Objectives
1 To examine a second within-parent factor ie parental perception of child vulnerability as a predictor or correlate of child adjustment to pediatric cancer
2 To examine a second within-parent factor ie parental perception of child vulnerability as a predictor or correlate of school reintegration ie school attendance in children with pediatric cancer
3 To develop a statistical model by which relative contributions of each predictor variable ie severity of illness quality of life parental stress parental perception of child vulnerability as well as their interrelatedness can be understood in relation to child adjustment Exploration of each variables contribution will affect the schematic organization of the model
4 To examine demographic variables as covariates in the primary analyses The variables include childs age gender grade ethnicity diagnosis time since diagnosis type and duration of treatment and time since school reintegration
1 To examine illness-related factors ie severity of illness quality of life rating as predictors or correlates of child adjustment to pediatric cancer
2 To examine illness-related factors ie severity of illness quality of life rating as predictors of school reintegration ie school attendance in children with pediatric cancer
3 To examine a within-parent factor ie parental stress as a predictor or correlate of child adjustment to pediatric cancer
4 To examine a within-parent factor ie parental stress as a predictor or correlate of school reintegration ie school attendance
Secondary Objectives
1 To examine a second within-parent factor ie parental perception of child vulnerability as a predictor or correlate of child adjustment to pediatric cancer
2 To examine a second within-parent factor ie parental perception of child vulnerability as a predictor or correlate of school reintegration ie school attendance in children with pediatric cancer
3 To develop a statistical model by which relative contributions of each predictor variable ie severity of illness quality of life parental stress parental perception of child vulnerability as well as their interrelatedness can be understood in relation to child adjustment Exploration of each variables contribution will affect the schematic organization of the model
4 To examine demographic variables as covariates in the primary analyses The variables include childs age gender grade ethnicity diagnosis time since diagnosis type and duration of treatment and time since school reintegration
Detailed Description:
Consent for Child Participation
STUDY PARTICIPATION
If you agree to take part in this study you will complete 3 paper-and-pencil questionnaires that will be used to get information about your health status and overall well being You will be asked how you are feeling at this time whether you worry a lot of the time how often you feel sad and how physically active you are such as with walking and running The study staff is also interested in knowing how well you are keeping up with school activities and how often you attend school Finally your doctor will provide information about your illness and describe how it may affect your participation at home or at school
If you are age 8 or above it should take about 30-45 minutes to complete the questionnaires If you are between age 6 and 7 it should take about 10-15 minutes to complete the questionnaires
Your parent or caregiver may be present while you complete your questionnaires However you are encouraged you to give your own answers The questionnaires may be completed in The Childrens Cancer Hospital clinic or elsewhere and a research assistant will assist you if you need help
Length of Study
Your participation in this study will be over once you have completed the 3 questionnaires
This is an investigational study Up to 106 children will take part in this study All will be enrolled at M D Anderson
Consent for Medical Staff Participants
Child Adjustment to Pediatric Cancer and School Reintegration
Researchers want to examine illness-related factors such as severity of illness and quality of life as predictors or correlates of adjustment to pediatric cancer and predictors of school reintegration such as school attendance of children with pediatric cancer
Study Participation
If you agree to take part in this study you will complete one 7-item paper-and-pencil measure that will be used to obtain information about your patients current health status For example the first question asks On a Likert scale of 1 to 7 describe the degree of impairment for this child One 1 indicates Independent functioning requires no assistance and 7 indicates Requires complete assistance It should take about 2-5 minutes to complete the measure in the clinic or your office and it can be done during regular work hours
You will also be asked to describe information on the childs severity of illness For example you will be asked to describe the degree of impairment frequency of medical procedureshospitalizations and your understanding of the childs participation in community activities
Length of Study
Your participation in this study will be over once you have completed the measure Study results will be published and mailed to each medical staff participant
This is an investigational study Up to 24 medical staff members will take part in this study All will be enrolled in this study at M D Anderson
Consent for Parent or Caregiver Participation
Child Adjustment to Pediatric Cancer and School Reintegration
Researchers want to learn about illness-related factors such as severity of illness and quality of life that may show how well children with cancer adjust to the disease and return to a traditional school setting by looking at school attendance for example
Your Study Participation
If you agree to take part in this study you will complete 5 paper-and-pencil questionnaires that will be used to get information about you and your childs health status Questions will be about your childs physical emotional and social functioning as well as how they are functioning in school You will be asked to rate how much of a problem you think your child may be having in these areas You will also be asked about how often difficult events have occurred for you as a parent or caregiver of a child with cancer These questionnaires should take about 45 minutes to 1 hour to complete
The Childs Participation
Your child will also be asked to complete 3 paper-and-pencil questionnaires that will also be used to get information about his or her health status as well as his or her overall well being
You may be present with your child while he or she is completing the questionnaires if you choose However you are encouraged to allow the child to complete the questionnaires on his or her own so as not to influence the childs answers A research assistant will be glad to assist your child with his or her completion of the questionnaires
Location for Completion of Questionnaires
The questionnaires for both you and the child may be completed in a private consultation room or examination room in The Childrens Cancer Hospital clinic or they may be completed outside of the room or clinic and returned to study staff
If they are completed outside of the room or clinic you can hand deliver the questionnaires to the clinic in an envelope or you can mail them back to study staff in a postage-paid return envelope that can be provided to you
Length of Study
Your participation in this study will be over once you have completed the 5 questionnaires You may receive a summary of the studys findings at the end of the study if you make this request to the study researcher who gave the questionnaires to the study doctor
This is an investigational study Up to 106 parents or caregivers will take part in this study All will be enrolled at M D Anderson
STUDY PARTICIPATION
If you agree to take part in this study you will complete 3 paper-and-pencil questionnaires that will be used to get information about your health status and overall well being You will be asked how you are feeling at this time whether you worry a lot of the time how often you feel sad and how physically active you are such as with walking and running The study staff is also interested in knowing how well you are keeping up with school activities and how often you attend school Finally your doctor will provide information about your illness and describe how it may affect your participation at home or at school
If you are age 8 or above it should take about 30-45 minutes to complete the questionnaires If you are between age 6 and 7 it should take about 10-15 minutes to complete the questionnaires
Your parent or caregiver may be present while you complete your questionnaires However you are encouraged you to give your own answers The questionnaires may be completed in The Childrens Cancer Hospital clinic or elsewhere and a research assistant will assist you if you need help
Length of Study
Your participation in this study will be over once you have completed the 3 questionnaires
This is an investigational study Up to 106 children will take part in this study All will be enrolled at M D Anderson
Consent for Medical Staff Participants
Child Adjustment to Pediatric Cancer and School Reintegration
Researchers want to examine illness-related factors such as severity of illness and quality of life as predictors or correlates of adjustment to pediatric cancer and predictors of school reintegration such as school attendance of children with pediatric cancer
Study Participation
If you agree to take part in this study you will complete one 7-item paper-and-pencil measure that will be used to obtain information about your patients current health status For example the first question asks On a Likert scale of 1 to 7 describe the degree of impairment for this child One 1 indicates Independent functioning requires no assistance and 7 indicates Requires complete assistance It should take about 2-5 minutes to complete the measure in the clinic or your office and it can be done during regular work hours
You will also be asked to describe information on the childs severity of illness For example you will be asked to describe the degree of impairment frequency of medical procedureshospitalizations and your understanding of the childs participation in community activities
Length of Study
Your participation in this study will be over once you have completed the measure Study results will be published and mailed to each medical staff participant
This is an investigational study Up to 24 medical staff members will take part in this study All will be enrolled in this study at M D Anderson
Consent for Parent or Caregiver Participation
Child Adjustment to Pediatric Cancer and School Reintegration
Researchers want to learn about illness-related factors such as severity of illness and quality of life that may show how well children with cancer adjust to the disease and return to a traditional school setting by looking at school attendance for example
Your Study Participation
If you agree to take part in this study you will complete 5 paper-and-pencil questionnaires that will be used to get information about you and your childs health status Questions will be about your childs physical emotional and social functioning as well as how they are functioning in school You will be asked to rate how much of a problem you think your child may be having in these areas You will also be asked about how often difficult events have occurred for you as a parent or caregiver of a child with cancer These questionnaires should take about 45 minutes to 1 hour to complete
The Childs Participation
Your child will also be asked to complete 3 paper-and-pencil questionnaires that will also be used to get information about his or her health status as well as his or her overall well being
You may be present with your child while he or she is completing the questionnaires if you choose However you are encouraged to allow the child to complete the questionnaires on his or her own so as not to influence the childs answers A research assistant will be glad to assist your child with his or her completion of the questionnaires
Location for Completion of Questionnaires
The questionnaires for both you and the child may be completed in a private consultation room or examination room in The Childrens Cancer Hospital clinic or they may be completed outside of the room or clinic and returned to study staff
If they are completed outside of the room or clinic you can hand deliver the questionnaires to the clinic in an envelope or you can mail them back to study staff in a postage-paid return envelope that can be provided to you
Length of Study
Your participation in this study will be over once you have completed the 5 questionnaires You may receive a summary of the studys findings at the end of the study if you make this request to the study researcher who gave the questionnaires to the study doctor
This is an investigational study Up to 106 parents or caregivers will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
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?:
None