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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
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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활성 비교기: 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
다른 이름들:
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
기간: 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
기간: 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
기간: Change from baseline to post intervention, around 8 weeks after baseline
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Sleep duration will be obtained by self-report from responses to the PSQI
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Change from baseline to post intervention, around 8 weeks after baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in change of SF-12 score from baseline to post-intervention between groups
기간: 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
기간: 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
기간: Change from baseline to 6 months post intervention
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Long term 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 6 months post intervention
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Difference in change in Insomnia Severity Index (ISI) score between groups
기간: Change from baseline to 6 months post intervention
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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 6 months post intervention
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Difference in change in sleep duration between groups
기간: Change from baseline to 6 months post intervention
|
Sleep duration will be obtained by self-report from responses to the PSQI
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Change from baseline to 6 months post intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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