Clinical trial · Interventional
Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
NCT03328169CI-TRIAL-00034358completedN/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)
Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.
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 Female | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | — | UNRESOLVED |
| Mindfulness-Based Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CBT-I
- description
- Cognitive Behavioral Therapy for Insomnia
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- type
- EXPERIMENTAL
- label
- Mindfulness
- description
- Mindfulness-Based Therapy
- interventionNames
- Behavioral: Mindfulness-Based Therapy
Primary outcomes (2)
- measure
- Change in Insomnia
- timeFrame
- Nine weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer * completed active treatment (surgery, radiation, chemotherapy) at least three months prior * within 5 years of treatment or still on adjuvant therapy * Completes informed consent to participate Exclusion Criteria: * sleep apnea or restless leg syndrome * practicing mindfulness techniques \>1/wk
References
Publications (0)
Data not yet available
No reference posted for this study.