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Social-Psychological Aspects of Orbital Exenteration

9. januar 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

33

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • UT MD Anderson Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patient
Diagnosis of orbital or head and neck cancer and a history of orbital exenteration.
Adfærdsmæssigt: 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.

Andre navne:
  • Undersøgelse
  • Spørgeskema
Adfærdsmæssigt: Questionnaire
5-10 minute questionnaire to be completed after the interview.
Andre navne:
  • Undersøgelse
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.
Adfærdsmæssigt: 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.

Andre navne:
  • Undersøgelse
  • Spørgeskema

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Participants evaluated at one time point (Interview - Questionnaire)
Participants evaluated at one time point (Interview - Questionnaire)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

M.D. Anderson Cancer Center

Efterforskere

  • Ledende efterforsker: Bita Esmaeli, MD, M.D. Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2008

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

15. januar 2008

Først indsendt, der opfyldte QC-kriterier

15. januar 2008

Først opslået (Skøn)

28. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2007-0584

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Øjenkræft

Kliniske forsøg med Audio-Taped Interview

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Rwanda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner