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

NCT02613923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-05-09

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

GO! To Sleep

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

BEHAVIORAL

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.

OTHER

Insomnia Severity Index (ISI)

OTHER

SF-12 quality of life survey

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Cheryl Thompson, PhD · University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-04
Primary Completion
2017-03-23
Completion
2017-07-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613923 on ClinicalTrials.gov