Clinical trial · Observational
The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
NCT07341503CI-TRIAL-00100806recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is being done to learn more about breast cancer patients' experiences with sleep changes during cancer treatment, identify possible reasons for poor sleep quality, and to find out how stress, social support, and living environment affect sleep.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hormone Receptor-Positive Breast Carcinoma | Hormone Receptor-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo collection of cheek swab, saliva, and hair samples, wear a wrist sleep tracking device, and complete surveys throughout the study. Additionally, patients have their medical records reviewed on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (2)
- measure
- Total sleep duration
- timeFrame
- Through study completion, an average of 9 months
- description
- Will report descriptive statistics of the sample characteristics using counts and percentages or means and standard deviations. Actigraphy from the sleep watch (GENEActiv device) will be scored and analyzed using validated algorithms within the Activeinsights software (Activinsights, UK). Daily and weekly summaries of sleep statistics will be averaged to generate person-level data for analysis at each time point. a paired t-test to compare T1 sleep duration (pre-treatment) to T3 (treatment completion) sleep duration using SAS PROC POWER.
- measure
- Self-reported sleep quality (PROMIS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \* Age \>= 18 years old at time of breast cancer diagnosis * Stage I to III breast cancer diagnosis * Hormone receptor positive breast cancers * Post primary surgery, before chemotherapy/radiation therapy begins * No known evidence of breast cancer recurrence (local or distant) or second, primary cancer * No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer) * Able to speak, understand and read English * Cognitively able to complete the study requirements * Ability to access medical records from treating hospital Exclusion Criteria: * \* Stage IV or metastatic breast cancer * Not cognitively able to provide informed consent * Not willing to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.