Social-Psychological Aspects of Orbital Exenteration

NCT00601744 | Completed

• 1 other identifier: 2007-0584
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eye Cancer

Keywords

Orbital Exenteration; Eye Cancer; Social-Psychological Aspects; Quality of Life; Questionnaire; Facial Appearance; Survey; Interview

Outcome Measures

Primary Outcomes (1)

• 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

  Participants evaluated at one time point (Interview - Questionnaire)

Study Arms (2)

Patient

Diagnosis of orbital or head and neck cancer and a history of orbital exenteration.

Behavioral: Audio-Taped Interview; Behavioral: Questionnaire

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

Interventions

Audio-Taped Interview BEHAVIORAL

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.

Also known as: Survey, Questionnaire

Family Member/Friend; Patient

Questionnaire BEHAVIORAL

5-10 minute questionnaire to be completed after the interview.

Also known as: Survey

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Eye Neoplasms; Facies

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Bita Esmaeli, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

US (1)