Improving the Sleep of Cancer Patients Using an Internet-Based Program (SHUTi-C)
2010年2月24日 更新者：University of Virginia
Evaluating Internet-Based Interventions for Insomnia in Cancer Patients
The purpose of this study is to determine whether an Internet-based program, Sleep Healthy Using the Internet (SHUTi, or "Shut-Eye"), can help to improve the sleep of people who are in remission from cancer and experiencing symptoms of insomnia.
調査の概要
詳細な説明
The purpose of this study is to test the feasibility of using an Internet program to improve the sleep of cancer patients with insomnia.
Participants will receive access to the Internet program (called SHUTi, or "Shut-Eye") as well as to self-hypnosis recordings designed to improve sleep.
SHUTi provides an online, tailored educational program to individuals who are experiencing sleep difficulties, including those having difficulty falling asleep, waking in the middle of the night, and waking too early in the morning.
研究の種類
介入
入学 (予想される)
22
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Virginia
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Charlottesville、Virginia、アメリカ、22908
- University of Virginia Department of Psychiatry & Neurobehavioral Sciences
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age = At least 21 years old
- Regular access to the Internet, including e-mail
Cancer patient
- Any type of cancer (EXCEPT non-melanoma skin cancer)
- In remission from any stage of cancer (active treatment completed at least one month prior to enrollment)
Insomnia diagnosis (combined from DSM-IV and ICSD):
- Subjective complaints of poor sleep for at least 6 months
- Sleep difficulties ≥3 nights/week
- Difficulty falling asleep (≥30 minutes to fall asleep) OR
Difficulty staying asleep (≥30 minutes awake in the middle of the night)
- ≤6.5 hours sleep/night
- Poor sleep causes marked distress or significant impairment in daytime functioning (e.g. fatigue, performance deficits, mood disturbance)
- Participant feels that the insomnia was caused/aggravated by cancer or cancer treatment
Exclusion Criteria:
- Having a sleep disorder other than insomnia (e.g. sleep apnea, RLS, narcolepsy, parasomnias)
- Having a medical condition other than cancer that causes insomnia
- Experiencing a psychiatric disturbance (major depression, psychosis)
- Experiencing substance abuse
- Currently undergoing psychotherapy or counseling
- Changing sleep/anxiety/depression medication within the past month
Having an "unusual" sleep pattern
- Normal bedtime is after 2am OR
- Normal wake time is after 9am
- Working as a shift worker (that is, having a schedule that requires working through the night)
- Participants reports that she is pregnant or intending to get pregnant in the next 4 months
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ImmedSHUTi/ImmedHyp
In the first part of the trial, participants are assigned to the Immediate SHUTi group; that is, they receive access to the SHUTi program right away.
In the second part of the trial (3 months later), participants are assigned to the Immediate Hypnosis group; that is, they receive access to the Hypnosis recordings right away.
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SHUTi is an Internet program based on cognitive-behavioral therapy for insomnia (CBT-I).
Users complete daily online sleep diaries in addition to receiving weekly access to six interactive "Cores" of information.
As they progress through the program, users receive tailored instructions for how to improve their sleep.
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
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実験的：ImmedSHUTi/DelayHyp
In the first part of the trial, participants are assigned to the Immediate SHUTi group; that is, they receive access to the SHUTi program right away.
In the second part of the trial (3 months later), participants are assigned to the Delayed Hypnosis group; that is, they receive access to the Hypnosis recordings at the end of the study.
|
SHUTi is an Internet program based on cognitive-behavioral therapy for insomnia (CBT-I).
Users complete daily online sleep diaries in addition to receiving weekly access to six interactive "Cores" of information.
As they progress through the program, users receive tailored instructions for how to improve their sleep.
|
|
実験的：DelaySHUTi/ImmedHyp
In the first part of the trial, participants are assigned to the Delayed SHUTi group; that is, they receive access to the SHUTi program at the end of the study.
In the second part of the trial (3 months later), participants are assigned to the Immediate Hypnosis group; that is, they receive access to the Hypnosis recordings right away.
|
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
|
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介入なし：DelaySHUTi/DelayHyp
In the first part of the trial, participants are assigned to the Delayed SHUTi group; that is, they receive access to the SHUTi program at the end of the study.
In the second part of the trial (3 months later), participants are assigned to the Delayed Hypnosis group; that is, they receive access to the Hypnosis recordings at the end of the study.
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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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Insomnia Severity Index (ISI)
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sleep Diary: Sleep Efficiency
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sleep Diary: Total Sleep Time
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Sleep Diary: Sleep Onset Latency (SOL)
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sleep Diary: Wake After Sleep Onset (WASO)
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sleep Diary: Number of Nighttime Awakenings
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Hospital Depression and Anxiety Scale
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Pain scale
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Multidimensional Fatigue Symptom Inventory
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Quality of Life (SF-12 Health Survey)
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Hot flashes
時間枠：prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Lee M Ritterband, Ph.D.、University of Virginia
- 主任研究者：Lora D Baum, Ph.D.、University of Virginia
- スタディディレクター：Elaine T Bailey, Ph.D.、University of Virginia
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年7月1日
一次修了 (実際)
2009年11月1日
研究の完了 (実際)
2009年11月1日
試験登録日
最初に提出
2008年6月18日
QC基準を満たした最初の提出物
2008年7月14日
最初の投稿 (見積もり)
2008年7月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2010年2月25日
QC基準を満たした最後の更新が送信されました
2010年2月24日
最終確認日
2010年2月1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。