mHealth for Breast Cancer Survivors With Insomnia

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is a Phase II SBIR to further test efficacy of a voice-activated technology to deliver components of cognitive behavioral therapy for insomnia (CBT-I) to breast cancer survivors (BCS) compared to a web-based control. Participants will be randomly assigned to the voice-activated or web-based treatment arms and will complete a 6-week intervention.

Official Title
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Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors

Conditions
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Insomnia, Breast Cancer Survivor

Intervention / Treatment
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* Behavioral: Faster Asleep Smart Speaker Program
* Behavioral: Faster Asleep Website


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voice-Activated Smart Speaker Program<br>Faster Asleep | Behavioral: Faster Asleep Smart Speaker Program<br>* Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia.<br>|
| Active Comparator: Website<br>Faster Asleep Website | Behavioral: Faster Asleep Website<br>* Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Symptoms | Data will be collected on the Insomnia Severity Index (ISI) total score pre- and post-intervention as our primary outcome. The ISI is a seven-item questionnaire with response categories from 0-4 (total score 0-28) asking about sleep patterns and specifically characterizing insomnia over the two weeks prior. The ISI defines 'no clinically significant' insomnia as a score of 0-7, 'sub-threshold' insomnia as a score of 8-14, 'moderate severity clinical' insomnia' a scores of 15-21, and 'severe clinical' insomnia as a score of 22-28. Clinically relevant target for success is to achieve sub-threshold or better scores (≤14) among >80% of the intervention participants | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | Sleep efficiency is calculated by the total time sleeping over the total time in bed. | 6 weeks | 
| Wake after sleep onset | Amount of time awake during the night | 6 weeks | 
| Sleep onset latency | Time to fall asleep | 6 weeks | 
| Total sleep time | Total time asleep | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Survivor, Insomnia, mHealth, Digital Health, Cognitive Behavioral Therapy for Insomnia (CBT-I)