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Social-Psychological Aspects of Orbital Exenteration

9 stycznia 2013 zaktualizowane przez: M.D. Anderson Cancer Center

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

33

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77030
        • UT MD Anderson Cancer Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Patient
Diagnosis of orbital or head and neck cancer and a history of orbital exenteration.
Behawioralne: 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.

Inne nazwy:
  • Ankieta
Behawioralne: Questionnaire
5-10 minute questionnaire to be completed after the interview.
Inne nazwy:
  • Ankieta
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.
Behawioralne: 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.

Inne nazwy:
  • Ankieta

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
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
Ramy czasowe: Participants evaluated at one time point (Interview - Questionnaire)
Participants evaluated at one time point (Interview - Questionnaire)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

M.D. Anderson Cancer Center

Śledczy

  • Główny śledczy: Bita Esmaeli, MD, M.D. Anderson Cancer Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2008

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2013

Ukończenie studiów (Rzeczywisty)

1 stycznia 2013

Daty rejestracji na studia

Pierwszy przesłany

15 stycznia 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 stycznia 2008

Pierwszy wysłany (Oszacować)

28 stycznia 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

10 stycznia 2013

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 stycznia 2013

Ostatnia weryfikacja

1 stycznia 2013

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2007-0584

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Rak oka

Badania kliniczne na Audio-Taped Interview

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Warunki

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