Social-Psychological Aspects of Survivorship in Cancer Patients After Orbital Exenteration: Issues Stemming From Alterations of Normal Facial Appearance
18 Years
N/A
Both
Eye Cancer
Trial Information
Social-Psychological Aspects of Survivorship in Cancer Patients After Orbital Exenteration: Issues Stemming From Alterations of Normal Facial Appearance
Family Members:
Study Interview:
If you agree to take part in this study, you will meet with a research staff member
(preferably in person, or else by phone) for an interview. During the interview, you will
be asked questions about your demographic information (such as your age, education level,
and marital status). You will be asked about your family member's medical history,
emotional well-being, appearance, and the types of social relations and support in his/her
life (such as relationships with friends and family).
You will also be asked if and how these social relations may have been affected by his/her
cancer experiences after the orbital exenteration. The interview should take about 2 to 2
1/2 hours. It will be audio-taped, and the interviewer will be taking notes. Your
responses in the interview will not be shared with the patient.
Additional Information:
If your interview responses show that you may be having emotional difficulties or
depression, you will be provided with names of mental health providers in case you would
like to receive mental health screening.
Length of Study Participation:
After the interview, your participation in this study will be over.
This is an investigational study.
Up to 40 people (20 patients and 20 family members) will take part in this study. All will
be enrolled at MD Anderson.
Patients:
Study Interview:
If you agree to take part in this study, a research staff member will schedule you for an
interview. During the interview, you will be asked questions about your demographic
information (such as your age, education level, and marital status) and medical history.
You will also be asked about your emotional well-being, how you feel about your appearance,
how you are coping with the cancer, and the types of social relations and support you have
in your life (such as relationships with friends and family). The interview should take
about 2 to 2 1/2 hours. It will be audio-taped, and the interviewer will be taking notes.
Additional Information:
Your responses in the interview will not be shared with your doctor. If you feel you need a
doctor's opinion about anything that is asked about in the questionnaire (such as mental or
emotional difficulties), please contact your doctor.
If your interview responses show that you may be having emotional difficulties or
depression, you will be provided with names of mental health providers in case you would
like to receive mental health screening.
Interview for Family Members:
For each eligible patient who agrees to take part in this study, one family member must also
agree to participate. Researchers will ask you for a family member whom researchers can
contact by phone to ask if he or she would agree to take part in this study. Your family
member's participation would involve being interviewed about his or her opinions of the same
questions that you were asked about in your interview. If your family member agrees, his or
her interview will be scheduled. If that family member does not agree to take part, another
family member may take part in his or her place. If no family members agree to take part,
your interview will not be scheduled and you will not be enrolled on the study.
Length of Study Participation:
After you complete the interview, your participation in this study will be over.
This is an investigational study.
Up to 40 people (20 patients and 20 family members) will take part in this study. All will
be enrolled at MD Anderson.
Inclusion Criteria:
1. Age 18 years or older (for both patient & family member).
2. Must be able to communicate in a meaningful manner with the investigators (for both
patient & family member).
3. Must be able to provide written/oral informed consent to participate (for both
patient & family member).
4. A diagnosis of orbital or head and neck cancer and a history of orbital exenteration
(for patient only). A family member or close friend of a patient with a diagnosis of
orbital or head and neck cancer and a history of orbital exenteration (for family
member only).
5. Must have obvious facial appearance change in the orbital area due to cancer
treatment (for patient only). A family member or close friend of a patient with
obvious facial appearance change in the orbital area due to cancer treatment (for
family member only).
6. Must have a family member willing to participate in a separate interview (for patient
only). Must be willing to participate in a separate interview (for both patient &
family member).
7. Must be English speaking (for both patient & family member).
Exclusion Criteria:
1. Significant pre-existing facial disfigurement from a congenital defect or other
disease or injury (for patient only).
2. Has recurrence of cancer and currently under treatment (for patient only).
3. Diagnosis of a serious mental disorder involving psychotic processes (such as formal
thought disorder and schizophrenia) documented in medical record or otherwise
apparent (for both patient & family member).
4. A foreign national (an individual who does not normally reside in the United States).
These patients are excluded due to the confounding variables that cultural
differences and language barriers may introduce (for both patient & family member).
Type of Study:
Observational
Study Design:
Observational Model: Family-Based, Time Perspective: Prospective
Outcome Measure:
List of physical adaptation and social-psychological issues cancer patients who survive and suffer from changes in normal facial appearance as a result of orbital exenteration
Outcome Time Frame:
Participants evaluated at one time point (Interview - Questionnaire)
Safety Issue:
No
Principal Investigator
Bita Esmaeli, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2007-0584
NCT ID:
NCT00601744
Start Date:
January 2008
Completion Date:
January 2013
Related Keywords:
- Eye Cancer
- Orbital Exenteration
- Eye Cancer
- Social-Psychological Aspects
- Quality of Life
- Questionnaire
- Facial Appearance
- Survey
- Interview
- Eye Neoplasms
- Facies
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
