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Psychosocial Predictors of Child Adjustment and School Reintegration Outcome in a Pediatric Cancer Population


N/A
6 Years
17 Years
Not Enrolling
Both
Pediatric Cancers

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Trial Information

Psychosocial Predictors of Child Adjustment and School Reintegration Outcome in a Pediatric Cancer Population


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
Children's 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 patient's 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 child's severity of illness. For
example, you will be asked to describe the degree of impairment, frequency of medical
procedures/hospitalizations, and your understanding of the child's 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 child's health status. Questions
will be about your child's 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 Child's 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 child's 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 Children's 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 study's 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.


Inclusion Criteria:



1. Children between 6 and 17 years diagnosed with, and treated for, any type of cancer

2. Children enrolled in grades K through 12

3. Children who have actively participated in community or private school during the
2006-2007 academic year

4. Children who have experienced a period of absence from community or private school of
at least two consecutive months as a result of medical treatment prior to school
reintegration

5. Children who have fully reintegrated as a full-time student within the past 1-3 years

6. Parents and children who are either English- or Spanish-speaking and are able to read
in either or both languages

7. Medical staff (i.e., physicians, nurse practitioners) involved in the children's
medical decision-making

Exclusion Criteria:

1. Children and/or parents diagnosed and/or identified as having mental retardation (IQ
< 70) with concomitant adaptive behavior deficits or classified as having any type of
Pervasive Developmental Disorder (PDD)

2. Children and/or parents who speak a language other than English or Spanish

3. Participant (e.g., parent or child) unwillingness to participate in any capacity

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Severity of Illness [using The Severity of Illness Scale (SOIS)]

Outcome Time Frame:

Completion of scale by medical staff, approximately 2-5 minutes

Safety Issue:

No

Principal Investigator

Martha Askins, PhD, BA, MA

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0007

NCT ID:

NCT00477256

Start Date:

May 2007

Completion Date:

October 2010

Related Keywords:

  • Pediatric Cancers
  • Pediatric Cancer
  • Child Adjustment
  • School Reintegration
  • Caregiver
  • Questionnaire
  • Quality of Life
  • Survey

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030