Clinical trial · Interventional
mHealth for Breast Cancer Survivors With Insomnia
Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors
NCT05233800CI-TRIAL-00085058completedN/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 aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial.
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 Survivor | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Faster Asleep Smart Speaker Program | Behavioral | — | UNRESOLVED |
| Faster Asleep Website | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Voice-Activated Smart Speaker Program
- description
- Faster Asleep
- interventionNames
- Behavioral: Faster Asleep Smart Speaker Program
- type
- ACTIVE_COMPARATOR
- label
- Website
- description
- Faster Asleep Website
- interventionNames
- Behavioral: Faster Asleep Website
Primary outcomes (1)
- measure
- Insomnia Symptoms
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willingness to maintain a consistent dosing pattern if currently taking sleep medications or using cannabis for sleep * Females; Age 18+ * Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1 * Completed curative treatment (surgery, radiation, chemotherapy) \> 3 months prior to enrollment \[ongoing adjuvant therapy permitted\] * Has not undergone other behavioral sleep treatment within the prior 12 months * Score greater than or equal to 8 on the Insomnia Severity Index * Able to understand and speak English Exclusion Criteria: * Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea * Bi-polar disorder, schizophrenia, initiation of psychological treatment within three months, alcohol or drug abuse in the prior year (Alcohol \>2 drinks/day or consuming 5+ drinks in a single day in the prior month). (Moderate ADHD, depression and anxiety will not be exclusion criteria.) * Shift-work in the prior three months or anticipated during the study time * Planned regular travel out of time zone (\>1 hour) during the study period. * Currently or planning to become pregnant during the study period
References
Publications (4)
- 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
- DERIVEDStarling CM, Greenberg D, Lewin D, Shaw C, Zhou ES, Lieberman D, Chou J, Arem H. Voice-Activated Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435011. doi: 10.1001/jamanetworkopen.2024.35011. PMID 39316400
- DERIVEDLewin D, Starling CM, Zhou ES, Greenberg D, Shaw C, Arem H. A novel voice interactive sleep log: concurrent validity with actigraphy and sleep diaries. J Clin Sleep Med. 2024 Feb 1;20(2):309-312. doi: 10.5664/jcsm.10878. PMID 37869974
- DERIVEDStarling CM, Greenberg D, Zhou E, Lewin D, Morrow AS, Lieberman D, Shaw C, Arem H. Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol. BMC Med Inform Decis Mak. 2022 Jun 21;22(1):163. doi: 10.1186/s12911-022-01902-w. PMID 35729605