Eye CancerNCT00601744
Social-Psychological Aspects of Orbital Exenteration
An observational study of Eye Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Cancer
- What is being tested?
- Audio-Taped Interview and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social-Psychological Aspects of Survivorship in Cancer Patients After Orbital Exenteration: Issues Stemming From Alterations of Normal Facial Appearance
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.
Read the detailed description
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.
- Conditions
- Eye Cancer
- Being tested
- Audio-Taped Interview, Questionnaire
- Keywords
- Orbital Exenteration, Eye Cancer, Social-Psychological Aspects, Quality of Life, Questionnaire, Facial Appearance, Survey, Interview
- Medical subject headings
- Eye Neoplasms, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-Taped InterviewBehavioural
Also called Survey, Questionnaire
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.
QuestionnaireBehavioural
Also called Survey
5-10 minute questionnaire to be completed after the interview.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Diagnosis of orbital or head and neck cancer and a history of orbital exenteration. Receives: 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. Receives: Behavioral: Audio-Taped Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants evaluated at one time point (Interview - Questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bita Esmaeli, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601744
- Sponsor's protocol ID
- 2007-0584
- Status last verified
- Jan 2013
- First submitted
- 15 Jan 2008
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social-Psychological Aspects of Survivorship in Cancer Patients After Orbital Exenteration: Issues Stemming From Alterations of Normal Facial Appearance
- ClinicalTrials.gov ID
- NCT00601744
- Acronym / sponsor ID
- 2007-0584
- Conditions
- Eye Cancer
- Keywords
- Orbital Exenteration, Eye Cancer, Social-Psychological Aspects, Quality of Life, Questionnaire, Facial Appearance, Survey, Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Behavioral: Audio-Taped Interview, Behavioral: QuestionnaireDiagnosis of orbital or head and neck cancer and a history of orbital exenteration. |
| Family Member/Friend | – | Behavioral: Audio-Taped InterviewFamily member or close friend of a patient with a diagnosis of orbital or head and neck cancer and a history of orbital exenteration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-Taped InterviewAlso: Survey, QuestionnaireMeeting 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. | Behavioural | Family Member/Friend, Patient |
| QuestionnaireAlso: Survey5-10 minute questionnaire to be completed after the interview. | Behavioural | Patient |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
Related trials for Eye Cancer
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
RecruitingPhase 2
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
Breast Cancer, Breast Cancer Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bita Esmaeli, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: Participants evaluated at one time point (Interview - Questionnaire)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.