A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Insomnia Sleep Studies |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/21/2019 |
| Start Date: | August 4, 2015 |
| End Date: | December 2019 |
| Contact: | Cheryl Thompson, PhD |
| Email: | cheryl.thompson@uhhospitals.org |
| Phone: | 216-368-3956 |
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.
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.
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.
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.
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.
We found this trial at
2
sites
Cleveland, Ohio 44195
Phone: 216-444-3052
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Cleveland, Ohio 44106
Phone: 216-368-3956
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