Social-Psychological Aspects of Orbital Exenteration
Social-Psychological Aspects of Survivorship in Cancer Patients After Orbital Exenteration: Issues Stemming From Alterations of Normal Facial Appearance
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- UT MD Anderson Cancer Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Patient
Diagnosis of orbital or head and neck cancer and a history of orbital exenteration.
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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.
他の名前：
5-10 minute questionnaire to be completed after the interview.
他の名前：
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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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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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
時間枠：Participants evaluated at one time point (Interview - Questionnaire)
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Participants evaluated at one time point (Interview - Questionnaire)
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協力者と研究者
捜査官
- 主任研究者：Bita Esmaeli, MD、M.D. Anderson Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2007-0584
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
眼がんの臨床試験
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McMaster UniversityIcahn School of Medicine at Mount Sinai; Edward-Elmhurst Health System完了霰粒腫 Unspecified Eye, Unspecified Eyelid | 霰粒腫左目、詳細不明のまぶた | 霰粒腫 右目、詳細不明のまぶた | 霰粒腫両目アメリカ, カナダ
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Audio-Taped Interviewの臨床試験
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Norwegian Institute of Public HealthStatistics Norway; Society of Interventional Oncology完了
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Damascus University完了