Social-Psychological Aspects of Orbital Exenteration
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Purpose
The goal of this research study is to learn about the social and emotional factors that may affect the quality of life of patients with cancer of the eye or eye area who have had their facial appearance changed due to an orbital exenteration.
| Condition | Intervention |
|---|---|
|
Eye Cancer |
Behavioral: Audio-Taped Interview Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Prospective |
| Official Title: | Social-Psychological Aspects of Survivorship in Cancer Patients After Orbital Exenteration: Issues Stemming From Alterations of Normal Facial Appearance |
- 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 [ Time Frame: Participants evaluated at one time point (Interview - Questionnaire) ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patient
Diagnosis of orbital or head and neck cancer and a history of orbital exenteration.
|
Behavioral: Audio-Taped Interview
Meeting with a research staff member either in person or by phone, lasting 2 to 2 1/2 hours Arm 1: Questions about emotional well-being, appearance, coping ability with the cancer, and the types of social relations and support available (such as relationships with friends and family) Arm 2: Questions regarding if and how social relations may have been affected by his/her cancer experiences after the orbital exenteration. Other Names:
Behavioral: Questionnaire
5-10 minute questionnaire to be completed after the interview.
Other Name: Survey
|
|
Family Member/Friend
Family member or close friend of a patient with a diagnosis of orbital or head and neck cancer and a history of orbital exenteration.
|
Behavioral: Audio-Taped Interview
Meeting with a research staff member either in person or by phone, lasting 2 to 2 1/2 hours Arm 1: Questions about emotional well-being, appearance, coping ability with the cancer, and the types of social relations and support available (such as relationships with friends and family) Arm 2: Questions regarding if and how social relations may have been affected by his/her cancer experiences after the orbital exenteration. Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patient diagnosis of orbital or head and neck cancer and a history of orbital exenteration. Family member or close friend of a patient with a diagnosis of orbital or head and neck cancer and a history of orbital exenteration.
Inclusion Criteria:
- Age 18 years or older (for both patient & family member).
- Must be able to communicate in a meaningful manner with the investigators (for both patient & family member).
- Must be able to provide written/oral informed consent to participate (for both patient & family member).
- 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).
- 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).
- 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).
- Must be English speaking (for both patient & family member).
Exclusion Criteria:
- Significant pre-existing facial disfigurement from a congenital defect or other disease or injury (for patient only).
- Has recurrence of cancer and currently under treatment (for patient only).
- 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).
- 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).
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Bita Esmaeli, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00601744 History of Changes |
| Other Study ID Numbers: | 2007-0584 |
| Study First Received: | January 15, 2008 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Orbital Exenteration Eye Cancer Social-Psychological Aspects Quality of Life |
Questionnaire Facial Appearance Survey Interview |
Additional relevant MeSH terms:
|
Eye Neoplasms Facies Neoplasms by Site Neoplasms |
Eye Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013