A Survey of Sleep Problems in Survivors of Breast Cancer
調査の概要
状態
条件
詳細な説明
Individuals who consent to participate in this study will be asked to complete a battery of questionnaires that will take approximately 1 hour. Based on answers they give to the questionnaires, 45 patients will be asked to participate in a sleep study done at a sleep lab.
If you choose to take part, then you will be asked to do the following:
Spend approximately 1 hour answering questionnaires either at the breast cancer center with a research assistant, at home on the phone with a research assistant, or by completing the questionnaires at home and returning them by mail. You will only be asked to complete questionnaires one time. The questionnaires will ask you questions about your:
- Past medical history
- Demographics
- Sleep quality
- Sleep habits
- Energy level, pain, daytime sedation
- Quality of life
- Menopausal symptoms
- Depression
- Fears
If you are then selected to participate in the sleep study, further information will be provided for you.
After you are finished with the questionnaires, the research assistant will provide you with any necessary further information and feedback. The research assistant will also be able to put you in contact with a study doctor should you require any further assistance. After you are finished with the study, the study doctor may contact you for clarification of your answer on a question, or for an answer if you have by any chance missed a question.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10021
- Memorial Sloan Kettering 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:
Subject Inclusion Criteria for Questionnaire Portion of Study
- Women with a diagnosis of Stage I, II, or III breast cancer who are one year posttreatment, but not more than 10 years post-treatment (surgery, chemotherapy, and/or radiation) prior to entrance into the study. Use of biological and/or hormonal therapy is acceptable.
- Greater than 18 years of age.
- Able to speak and read English.
Exclusion Criteria:
Subject Exclusion Criteria for Questionnaire Portion of Study •Evidence of acute or chronic encephalopathy or psychiatric disease severe enough to compromise data collection.
Exclusion Criteria for Sleep Lab Study
•Women who are unable or unwilling to avoid alcohol, caffeine consumption or cigarette smoking as of 3 p.m. on the day of the sleep study.
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 |
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1
15 subjects with subjective sleep disturbance based on the Pittsburgh Sleep Quality Index
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2
mild/moderate subjective sleep disturbance (insomnia) based on the Pittsburgh Sleep Quality Index
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3
severe subjective sleep disturbance (insomnia)based on the Pittsburgh Sleep Quality Index
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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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Determine the prevalence of cancer-related insomnia in women surviving breast cancer (Stage I, II, & III) who are at least one year, but not more than 10 years posttreatment & to study its deleterious impact on qol
時間枠：2 years
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2 years
|
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To describe the underlying physiology and nature of sleep disturbances in this cohort of women by performing sleep lab studies with a subset of the sample
時間枠：2 years
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2 years
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To survey the medical, demographic and psychosocial correlates of cancer-related insomnia in this cohort of women to identify subgroups with potentially differing etiologies and associated symptoms to help plan relevant intervention studies
時間枠：2 Years
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2 Years
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To preliminarily describe correlations between subgroups and sleep disturbances documented in the sleep lab studies
時間枠：2 years
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2 years
|
協力者と研究者
捜査官
- 主任研究者：Steven Passik, PhD、Memorial Sloan Kettering 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。