Clinical trial NCT02613923: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Sleep
Keywords: Breast Cancer
GO! to sleep
sleep
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 17
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
timeFrame: Change from baseline to post intervention, around 8 weeks after baseline
measure: Difference in change in Insomnia Severity Index (ISI) score between groups
timeFrame: Change from baseline to post intervention, around 8 weeks after baseline
measure: Difference in change in sleep duration between groups
timeFrame: Change from baseline to post intervention, around 8 weeks after baseline
Secondary outcomes:
measure: Difference in change of SF-12 score from baseline to post-intervention between groups
timeFrame: Change from baseline to 6 months post intervention
measure: Correlation of joint changes in biomarker levels with PSQI and ISI
timeFrame: Change from baseline to 6 months post intervention
measure: Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
timeFrame: Change from baseline to 6 months post intervention
measure: Difference in change in Insomnia Severity Index (ISI) score between groups
timeFrame: Change from baseline to 6 months post intervention
measure: Difference in change in sleep duration between groups
timeFrame: Change from baseline to 6 months post intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
name: Cheryl Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: