Smoking Status and Body Image in Oral Cancer Patients
A Prospective Examination of Smoking Status and Body Image in Surgical Patients With Cancer of the Oral Cavity
Primary Objectives:
- To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
- To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
- To examine the influence of smoking status and body image on quality of life outcomes.
調査の概要
詳細な説明
If you agree to take part in this study, researchers will first perform a test to check the level of carbon monoxide (CO) in your blood. To do this test, you will be asked to blow into a cardboard tube attached to a machine. You will then be asked to fill out some questionnaires and complete a one-on-one interview. All of these things combined will take about an hour to complete. You will be asked basic questions such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and how you feel about your appearance.
If you do not have surgery, your participation in this study will end after this visit. If you have surgery, you will be asked to come back for 2 more study visits, 1 month and 6 months after your surgery. During these evaluations, you will be asked once again to blow into the cardboard tube, fill out questionnaires, and a complete a one-on-one interview. Each visit will last about an hour. You will again be asked questions about your smoking behaviors, mood, quality of life, and how you feel about your appearance. Your participation in this study will be finished after the 6-month evaluation.
This is an investigational study. About 75 people will take part in this research study. All will be enrolled at M. D. 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
- University of Texas 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:
- 18 years of age or older
- Able to provide written informed consent to participate
- Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment
- Current treatment plan includes surgical intervention
- English speaking
Exclusion Criteria:
- Previous treatment for malignancy in the head and neck region
- Significant preexisting facial disfigurement from a previous trauma or congenital defect
- Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record.
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 |
|---|---|
|
Smoking Behavior Group
Individuals Having Surgery for Oral Cavity Cancer.
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Written survey at 1 Month & 6 Months post surgery.
One-on-One meeting lasting about one hour, at 1 Month & 6 Months post surgery.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.
時間枠：Baseline, 1 Month and 6 Months Post Surgery
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Preliminary analyses involve two-sample t-tests of difference in body image between male and female, one-way ANOVA to compare body image across ethnicity groups, and calculation of Pearson product moment correlation coefficients between body image and age.
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Baseline, 1 Month and 6 Months Post Surgery
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協力者と研究者
捜査官
- 主任研究者：Ellen R. Gritz, PhD、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
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。