A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer.
Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast cancer.
The purpose of this study is to compare women who get a sleep intervention to women who do not get a sleep intervention. This study team will compare these two groups of women to see if the sleep intervention improves their sleep and if it lowers markers of inflammation that have been associated with an increased risk of breast cancer.
調査の概要
状態
詳細な説明
Objective 1: To test the effectiveness of the GO! To Sleep program at improving the sleep duration and sleep quality in women at high risk of breast cancer.
Objective 2: To test the effectiveness of improvements in sleep quality and/or duration due to the GO! To Sleep program on biomarkers of inflammation in women at high risk of breast cancer.
Objective 3: To evaluate the effectiveness of improvements in health-related quality of life after the GO! To Sleep in women at high risk of breast cancer.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ohio
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Cleveland、Ohio、アメリカ、44106
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive 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
説明
Inclusion Criteria:
Women at high risk of breast cancer due to one or more of the following:
- Carry deleterious mutations in the BRCA1, BRCA2, PTEN, TP53, STK11, or CDH1 genes
- Previous diagnosis of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH)
- Lifetime risk of 20% or greater as calculated by the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool or the Tyrer-Cuzick IBIS Risk Assessment Tool
- Ability to access the internet and watch videos online.
- Valid email address.
- Self-reported sleep duration of 6 hours per night or less
Exclusion Criteria:
- Previous diagnosis of cancer.
- Lack of ability to read and converse in English.
- Lack of ability to give informed consent.
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
- 主な目的：防止
- 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：GO! To Sleep
Participants in the intervention group will be provided with a code and website address to participate in this program.
This program includes reminder emails and is 6 weeks in duration.
Participants will be given a blood draw to measure biomarkers.
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Controlled sleep intervention.
Provide online education and reminder emails on improving sleep behavior
blood sample measured for stress and sleep markers
他の名前：
Assessment of sleep quality.
This is a continuous measure from 0 (best) to 21 (worst).
Sleep duration will be obtained directly from responses.
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アクティブコンパレータ：informational control
Participants in the control group will receive weekly emails with sleep information and the health benefits of sleep for 6 weeks.Participants will be given a blood draw to measure biomarkers.
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blood sample measured for stress and sleep markers
他の名前：
Assessment of sleep quality.
This is a continuous measure from 0 (best) to 21 (worst).
Sleep duration will be obtained directly from responses.
Participants will receive weekly emails on the health benefits of sleep for 6 weeks
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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 |
|---|---|---|
|
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
時間枠：Change from baseline to post intervention, around 8 weeks after baseline
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Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
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Change from baseline to post intervention, around 8 weeks after baseline
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Difference in change in Insomnia Severity Index (ISI) score between groups
時間枠：Change from baseline to post intervention, around 8 weeks after baseline
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Sleep quality will be measured with the insomnia severity index (ISI).
A validated instrument for sleep quality
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Change from baseline to post intervention, around 8 weeks after baseline
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Difference in change in sleep duration between groups
時間枠：Change from baseline to post intervention, around 8 weeks after baseline
|
Sleep duration will be obtained by self-report from responses to the PSQI
|
Change from baseline to post intervention, around 8 weeks after baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in change of SF-12 score from baseline to post-intervention between groups
時間枠：Change from baseline to 6 months post intervention
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The effectiveness of changing health-related quality of life after the GO!
To Sleep program will he measured with the self-reported survey SF-12
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Change from baseline to 6 months post intervention
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Correlation of joint changes in biomarker levels with PSQI and ISI
時間枠：Change from baseline to 6 months post intervention
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This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
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Change from baseline to 6 months post intervention
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Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
時間枠：Change from baseline to 6 months post intervention
|
Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
|
Change from baseline to 6 months post intervention
|
|
Difference in change in Insomnia Severity Index (ISI) score between groups
時間枠：Change from baseline to 6 months post intervention
|
Sleep quality will be measured with the insomnia severity index (ISI).
A validated instrument for sleep quality
|
Change from baseline to 6 months post intervention
|
|
Difference in change in sleep duration between groups
時間枠：Change from baseline to 6 months post intervention
|
Sleep duration will be obtained by self-report from responses to the PSQI
|
Change from baseline to 6 months post intervention
|
協力者と研究者
捜査官
- 主任研究者：Cheryl Thompson, PhD、University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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