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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Breast Cancer; Sleep

Treatments: Other: Pittsburgh Sleep Quality Index (PSQI); Other: Insomnia Severity Index (ISI); Behavioral: Sleep information; Behavioral: GO! To Sleep; Other: SF-12 quality of life survey; Procedure: Blood Draw

Study type: Interventional

Funder types: Other

Identifiers

NCT02613923

CASE6114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

GO! To Sleep

Experimental group

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.

Treatment:

Procedure: Blood Draw

Other: Pittsburgh Sleep Quality Index (PSQI)

Other: Insomnia Severity Index (ISI)

Behavioral: GO! To Sleep

Other: SF-12 quality of life survey

informational control

Active Comparator group

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.

Treatment:

Procedure: Blood Draw

Other: Pittsburgh Sleep Quality Index (PSQI)

Other: Insomnia Severity Index (ISI)

Behavioral: Sleep information

Other: SF-12 quality of life survey