Clinical trial · Interventional
A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sleep | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Draw | Procedure | — | UNRESOLVED |
| GO! To Sleep | Behavioral | — | UNRESOLVED |
| Insomnia Severity Index (ISI) | Other | — | UNRESOLVED |
| Pittsburgh Sleep Quality Index (PSQI) | Other | — | UNRESOLVED |
| SF-12 quality of life survey | Other | — | UNRESOLVED |
| Sleep information | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GO! To Sleep
- 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.
- interventionNames
- Behavioral: GO! To Sleep
- Procedure: Blood Draw
- Other: Pittsburgh Sleep Quality Index (PSQI)
- Other: Insomnia Severity Index (ISI)
- Other: SF-12 quality of life survey
- type
- ACTIVE_COMPARATOR
- label
- informational control
- 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.
- interventionNames
- Behavioral: Sleep information
- Procedure: Blood Draw
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available