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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613923
• Other study ID #: CASE6114
• Status: Completed
• Phase: N/A
• Start date: August 4, 2015
• Est. completion date: July 23, 2017

Study information

• Verified date: May 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 23, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sleep

Intervention

Behavioral:
• GO! To Sleep
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
• Sleep information
Participants will receive weekly emails on the health benefits of sleep for 6 weeks

Procedure:
• Blood Draw
blood sample measured for stress and sleep markers

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.
• Insomnia Severity Index (ISI)

• SF-12 quality of life survey

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	Change from baseline to 6 months post intervention
Secondary	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	Change from baseline to 6 months post intervention
Secondary	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)	Change from baseline to 6 months post intervention
Secondary	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 6 months post intervention
Secondary	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 6 months post intervention