A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer

May 7, 2019 updated by: Case Comprehensive Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 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
  2. Ability to access the internet and watch videos online.
  3. Valid email address.
  4. Self-reported sleep duration of 6 hours per night or less

Exclusion Criteria:

  1. Previous diagnosis of cancer.
  2. Lack of ability to read and converse in English.
  3. Lack of ability to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: GO! To Sleep
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
Procedure: Blood Draw
blood sample measured for stress and sleep markers
Other Names:
  • biomarker measurement
Other: Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Other: Insomnia Severity Index (ISI)
Other: SF-12 quality of life survey
Active Comparator: 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.
Procedure: Blood Draw
blood sample measured for stress and sleep markers
Other Names:
  • biomarker measurement
Other: Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Other: Insomnia Severity Index (ISI)
Other: SF-12 quality of life survey
Behavioral: Sleep information
Participants will receive weekly emails on the health benefits of sleep for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Time Frame: Change from baseline to post intervention, around 8 weeks after baseline
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
Time Frame: Change from baseline to post intervention, around 8 weeks after baseline
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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in change of SF-12 score from baseline to post-intervention between groups
Time Frame: Change from baseline to 6 months post intervention
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
Change from baseline to 6 months post intervention
Correlation of joint changes in biomarker levels with PSQI and ISI
Time Frame: Change from baseline to 6 months post intervention
This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
Change from baseline to 6 months post intervention
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2015

Primary Completion (Actual)

March 23, 2017

Study Completion (Actual)

July 23, 2017

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE6114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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