Clinical trial · Interventional
Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy
Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial
- 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 randomized phase II trial studies how well brief behavioral therapy works in improving sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life in patients with breast cancer who are undergoing chemotherapy.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sleep Disorder | — | UNRESOLVED | — |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brief Behavioral Therapy | Behavioral | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Telephone-Based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (BBT intervention)
- description
- Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.
- interventionNames
- Behavioral: Brief Behavioral Therapy
- Behavioral: Telephone-Based Intervention
- type
- ACTIVE_COMPARATOR
- label
- Arm II (control)
- description
- Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.
- interventionNames
- Other: Educational Intervention
- Behavioral: Telephone-Based Intervention
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed breast cancer (stage I, II, III) * Be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least 6 weeks of chemotherapy treatment remaining; patients are eligible any time before chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle; (Note: use of biologics \[e.g., Herceptin (trastuzumab)\] is permitted) * For patients on a weekly regimen, there should be at least 3 dosages of chemotherapy remaining * For patients on either a 2 week or 3 week cycle, there should be at least 2 dosages of chemotherapy remaining * Patients will not be dropped from the study if their chemotherapy is discontinued after they are enrolled * Report sleep disturbance of 8 (sum total of all 7 items) or greater on the Insomnia Severity Index * (Note: this measure will be repeated again at baseline assessment) * Report sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?) * Be able to speak and read English * Patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded * Be able and willing to wear an Actiwatch for the entire 24 hours of each day they are scheduled to wear it Exclusion Criteria: * Have diagnosis of breast cancer stage IV * Have sleep problems that began before diagnosis and have not changed since diagnosis * Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol * Have a clinical diagnosis of sleep apnea or restless leg syndrome * Be unable or unwilling to discontinue anxiolytic medication within 4 hours of intervention sessions * Take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is permitted * Patients who are shift workers are excluded; shift worker is defined as someone who has irregular work and sleep hours (such as working a non-traditional schedule: e.g., 4pm-midnight or 10pm-6am; a rotating schedule e.g., alternating between day and night shifts, or starting work between 4am and 7am) * Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)
References
Publications (1)
- DERIVEDCai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. PMID 41170811