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Social-Psychological Aspects of Orbital Exenteration

9 gennaio 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

33

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • UT MD Anderson Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Patient
Diagnosis of orbital or head and neck cancer and a history of orbital exenteration.
Comportamentale: 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.

Altri nomi:
  • Indagine
  • Questionario
Comportamentale: Questionnaire
5-10 minute questionnaire to be completed after the interview.
Altri nomi:
  • Indagine
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.
Comportamentale: 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.

Altri nomi:
  • Indagine
  • Questionario

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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
Lasso di tempo: Participants evaluated at one time point (Interview - Questionnaire)
Participants evaluated at one time point (Interview - Questionnaire)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

M.D. Anderson Cancer Center

Investigatori

  • Investigatore principale: Bita Esmaeli, MD, M.D. Anderson Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2008

Completamento primario (Effettivo)

1 gennaio 2013

Completamento dello studio (Effettivo)

1 gennaio 2013

Date di iscrizione allo studio

Primo inviato

15 gennaio 2008

Primo inviato che soddisfa i criteri di controllo qualità

15 gennaio 2008

Primo Inserito (Stima)

28 gennaio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 gennaio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 gennaio 2013

Ultimo verificato

1 gennaio 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2007-0584

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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