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Social-Psychological Aspects of Orbital Exenteration
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2009
First Received: January 15, 2008   Last Updated: November 17, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00601744
  Purpose

Primary Objectives:

  • 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.
  • 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).
  • 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).

Condition Intervention
Eye Cancer
Behavioral: Audio-Taped Interview
Behavioral: Questionnaire

Study Type: Observational
Study Design: Family-Based, Prospective
Official Title: Social-Psychological Aspects of Survivorship in Cancer Patients After Orbital Exenteration: Issues Stemming From Alterations of Normal Facial Appearance

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 40
Study Start Date: January 2008
Estimated Primary Completion Date: January 2010 (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.

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


  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
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.

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601744

Contacts
Contact: Bita Esmaeli, MD 713-792-6920

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Bita Esmaeli, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Bita Esmaeli, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Bita Esmaeli, MD/Associate Professor )
Study ID Numbers: 2007-0584
Study First Received: January 15, 2008
Last Updated: November 17, 2009
ClinicalTrials.gov Identifier: NCT00601744     History of Changes
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:
Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site
Facies
Eye Neoplasms
Eye Diseases

ClinicalTrials.gov processed this record on February 08, 2010