Clinical trial · Interventional
Management of Insomnia in Breast Cancer Patients
Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
- 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)
To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). Participants will be randomized into 4 groups: * Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day. * Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day. * Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention. * Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.
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 |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Armodafinil | Drug | — | UNRESOLVED |
| BBT-I | Behavioral | — | UNRESOLVED |
| Control | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- BBT-I + Armodafinil
- description
- Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth.
- interventionNames
- Behavioral: BBT-I
- Drug: Armodafinil
- type
- EXPERIMENTAL
- label
- Behavioral placebo + Armodafinil
- description
- Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth.
- interventionNames
- Behavioral: Control
- Drug: Armodafinil
- type
- SHAM_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
INCLUSION CRITERIA * Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed) * Have at least 6 weeks of treatment remaining * ≥ 21 years old * Able to understand written and spoken English * Able to swallow medication (until amendment omitting armodafinil treatment) * Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI) EXCLUSION CRITERIA * Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment) * Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment) * Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment) * Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment) * History (self-reported) of unstable medical or psychiatric illness (within the last 5 years) * History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment) * Pregnant or nursing * History of substance abuse or meet criteria for current alcohol abuse or dependence * History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS) * Severe hepatic impairment (until amendment omitting armodafinil treatment)
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