Skip to main content
OpenTrials
Completed

NCT Number: NCT02613923

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Sleep

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Go! to Sleep

Behavioral

Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior

Sleep information

Behavioral

Participants will receive weekly emails on the health benefits of sleep for 6 weeks

Blood draw

Procedure

blood sample measured for stress and sleep markers

Other names: biomarker measurement

Pittsburgh Sleep Quality Index (PSQI)

Other

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)

Other

SF-12 quality of life survey

Other

Primary outcomes

  1. Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups

    Time frame: Change from baseline to post intervention, around 8 weeks after baseline

    Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)

  2. Difference in change in Insomnia Severity Index (ISI) score between groups

    Time frame: Change from baseline to post intervention, around 8 weeks after baseline

    Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality

  3. Difference in change in sleep duration between groups

    Time frame: Change from baseline to post intervention, around 8 weeks after baseline

    Sleep duration will be obtained by self-report from responses to the PSQI

Secondary outcomes

  1. Difference in change of SF-12 score from baseline to post-intervention between groups

    Time frame: Change from baseline to 6 months post intervention

    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

  2. Correlation of joint changes in biomarker levels with PSQI and ISI

    Time frame: Change from baseline to 6 months post intervention

    This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration

  3. Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups

    Time frame: Change from baseline to 6 months post intervention

    Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)

  4. Difference in change in Insomnia Severity Index (ISI) score between groups

    Time frame: Change from baseline to 6 months post intervention

    Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality

  5. Difference in change in sleep duration between groups

    Time frame: Change from baseline to 6 months post intervention

    Sleep duration will be obtained by self-report from responses to the PSQI

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2015
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.