Clinical trial · Interventional
Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment
NCT00672217CI-TRIAL-00018031RESTcompletedN/AClinicalTrials.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)
The primary goal of the proposed study is to examine a cognitive behavioral intervention for insomnia (CBTI) in women after breast cancer treatment. Chronic Insomnia is a highly prevalent and distressing symptom in cancer patients. CBTI is considered the treatment of choice for chronic primary insomnia. Few studies have been conducted in cancer survivors to evaluate the effect of CBTI on sleep and clinically relevant outcomes.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Placebo Treatment | Behavioral | — | UNRESOLVED |
| Cognitive Behavioral Therapy for Insomnia (CBTI) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Behavioral Placebo Therapy
- description
- Behavioral Placebo Treatment
- interventionNames
- Behavioral: Behavioral Placebo Treatment
- type
- ACTIVE_COMPARATOR
- label
- Cognitive Behavioral Therapy
- description
- Cognitive Behavioral Therapy for Insomnia (CBTI)
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)
Primary outcomes (1)
- measure
- sleep efficiency
- timeFrame
- baseline, pre and post intervention, 3-months, 6-months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 21 to 65 years of age inclusive * 1-36 months after radiation or chemotherapy for non-metastatic breast cancer and on a stable dose of anti-estrogen agent and medications for hot flashes * Meets diagnostic criteria for chronic, secondary insomnia * Speak and write English Exclusion Criteria: * Presence of a serious unstable physical illness other than cancer * Presence of dementia, major depression, psychosis or other serious psychiatric disorder * Presence of a sleep disorder other than insomnia * Unstable doses of psychotropic medications (excluding hypnotics), opioids, anit-endocrine medications, or use of high dose steroids * Current evening/night shift employment
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