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
1 other identifier
interventional
17
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2015
CompletedFirst Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2017
CompletedMay 9, 2019
May 1, 2019
1.6 years
November 23, 2015
May 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Change from baseline to post intervention, around 8 weeks after baseline
Difference in change in Insomnia Severity Index (ISI) score between groups
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Change from baseline to post intervention, around 8 weeks after baseline
Difference in change in sleep duration between groups
Sleep duration will be obtained by self-report from responses to the PSQI
Change from baseline to post intervention, around 8 weeks after baseline
Secondary Outcomes (5)
Difference in change of SF-12 score from baseline to post-intervention between groups
Change from baseline to 6 months post intervention
Correlation of joint changes in biomarker levels with PSQI and ISI
Change from baseline to 6 months post intervention
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Change from baseline to 6 months post intervention
Difference in change in Insomnia Severity Index (ISI) score between groups
Change from baseline to 6 months post intervention
Difference in change in sleep duration between groups
Change from baseline to 6 months post intervention
Study Arms (2)
GO! To Sleep
EXPERIMENTALParticipants 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.
informational control
ACTIVE COMPARATORParticipants 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.
Interventions
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
Participants will receive weekly emails on the health benefits of sleep for 6 weeks
blood sample measured for stress and sleep markers
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous diagnosis of cancer.
- Lack of ability to read and converse in English.
- Lack of ability to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl Thompson, PhD
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 25, 2015
Study Start
August 4, 2015
Primary Completion
March 23, 2017
Study Completion
July 23, 2017
Last Updated
May 9, 2019
Record last verified: 2019-05