Clinical trial · Interventional
Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
NCT04101526CI-TRIAL-00082032completedN/AResults postedClinicalTrials.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 purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
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 |
|---|---|---|---|
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Pre-Intervention Qualitative Interviews
- description
- Qualitative interviews will be conducted with breast cancer survivors, survivors' caregivers, cancer support group leaders and clinicians regarding sleep disturbance in breast cancer survivors and preferences for an intervention for sleep disturbance.
- type
- EXPERIMENTAL
- label
- Videoconference Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I)
- description
- Behavioral: New Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
- interventionNames
- Behavioral: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
- type
- NO_INTERVENTION
- label
- Waitlist control group
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Located in the Southern Puerto Rico area * Able to speak and read Spanish * Have no documented or observable disabilities that would interfere with study participation * Has completed primary treatment for breast cancer (e.g., surgery, chemotherapy, radiation) * Has clinically significant sleep disturbance (i.e., \>/= 8 on the Insomnia Severity Index) * Is at low risk of other sleep disorders that are not amenable to treatment with cognitive-behavioral therapy * Has access to the Internet and a digital device (e.g., smartphone) capable of using videoconference software Exclusion Criteria: * Not able to read and speak Spanish
References
Publications (2)
- 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
- DERIVEDOswald LB, Morales-Cruz J, Eisel SL, Del Rio J, Hoogland AI, Ortiz-Rosado V, Soto-Lopez G, Rodriguez-Rivera E, Savard J, Castro E, Jim HSL, Gonzalez BD. Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. J Behav Med. 2022 Jun;45(3):503-508. doi: 10.1007/s10865-022-00313-6. Epub 2022 Apr 19. PMID 35438442