MDACC Study Summary 2007-0584

Study Summary
No. 2007-0584:.......Eye; Head And Neck......Bita Esmaeli......Ophthalmology/Head & Neck Surgery

Study Summary Title



Study Summary Number:	2007-0584

Study Title:	Social-Psychological Aspects of Survivorship in Cancer Patients after Orbital Exenteration: Issues Stemming from Alterations of Normal Facial Appearance

Physician

New Patient Referral



Name:	Bita Esmaeli	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Ophthalmology/Head & Neck Surgery	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6920 Contact us about clinical trials

General Information



Disease Group:	Eye Head And Neck	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Once.

Treatment Agents:	None	Home Care:	N/A.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A.


Description/ Intervention:	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.

Study Objectives / Outcomes

1) To characterize the physical adaptation and social-psychological issues of cancer patients who survive and suffer from changes in their normal facial appearance as a result of orbital exenteration.
2) To characterize the social-psychological issues associated with the interactions between cancer patients who survive and suffer from changes in their normal facial appearance as a result of orbital exenteration and members of their primary groups (i.e., family members and friends).
3) To characterize the social-psychological issues associated with the interactions between cancer patients who survive and suffer from changes in their normal facial appearance as a result of orbital exenteration and members of their key secondary groups (i.e., those with whom they interact at work and in other formal social settings).

Study Status Information



Study Activation / Registration Date:	01/10/2008

IRB Review and Approval Date:	01/10/2008

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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).

Links

Registration Number: NCT00601744
Study Information on Clinical Trials Registry (clinicaltrials.gov)