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

Primary Purpose

Breast Cancer, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GO! To Sleep
Sleep information
Blood Draw
Pittsburgh Sleep Quality Index (PSQI)
Insomnia Severity Index (ISI)
SF-12 quality of life survey
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, GO! to sleep, sleep

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GO! To Sleep

informational control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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
Difference in change in sleep duration between groups
Sleep duration will be obtained by self-report from responses to the PSQI

Secondary Outcome Measures

Difference in change of SF-12 score from baseline to post-intervention between groups
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
Correlation of joint changes in biomarker levels with PSQI and ISI
This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
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
Difference in change in sleep duration between groups
Sleep duration will be obtained by self-report from responses to the PSQI

Full Information

First Posted
November 23, 2015
Last Updated
May 7, 2019
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02613923
Brief Title
A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
Official Title
A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 4, 2015 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
July 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Sleep
Keywords
Breast Cancer, GO! to sleep, sleep

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GO! To Sleep
Arm Type
Experimental
Arm Description
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.
Arm Title
informational control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
GO! To Sleep
Intervention Description
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
Intervention Type
Behavioral
Intervention Name(s)
Sleep information
Intervention Description
Participants will receive weekly emails on the health benefits of sleep for 6 weeks
Intervention Type
Procedure
Intervention Name(s)
Blood Draw
Other Intervention Name(s)
biomarker measurement
Intervention Description
blood sample measured for stress and sleep markers
Intervention Type
Other
Intervention Name(s)
Pittsburgh Sleep Quality Index (PSQI)
Intervention Description
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Intervention Type
Other
Intervention Name(s)
Insomnia Severity Index (ISI)
Intervention Type
Other
Intervention Name(s)
SF-12 quality of life survey
Primary Outcome Measure Information:
Title
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Description
Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Time Frame
Change from baseline to post intervention, around 8 weeks after baseline
Title
Difference in change in Insomnia Severity Index (ISI) score between groups
Description
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Time Frame
Change from baseline to post intervention, around 8 weeks after baseline
Title
Difference in change in sleep duration between groups
Description
Sleep duration will be obtained by self-report from responses to the PSQI
Time Frame
Change from baseline to post intervention, around 8 weeks after baseline
Secondary Outcome Measure Information:
Title
Difference in change of SF-12 score from baseline to post-intervention between groups
Description
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
Time Frame
Change from baseline to 6 months post intervention
Title
Correlation of joint changes in biomarker levels with PSQI and ISI
Description
This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
Time Frame
Change from baseline to 6 months post intervention
Title
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Description
Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Time Frame
Change from baseline to 6 months post intervention
Title
Difference in change in Insomnia Severity Index (ISI) score between groups
Description
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Time Frame
Change from baseline to 6 months post intervention
Title
Difference in change in sleep duration between groups
Description
Sleep duration will be obtained by self-report from responses to the PSQI
Time Frame
Change from baseline to 6 months post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Thompson, PhD
Organizational Affiliation
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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

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