mHealth for Breast Cancer Survivors With Insomnia

Not Applicable

Completed

Interventions: Behavioral: Faster Asleep Website
Behavioral: Faster Asleep Smart Speaker Program

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Website	Faster Asleep Website	Faster Asleep Website
Voice-Activated Smart Speaker Program	Faster Asleep Smart Speaker Program	Faster Asleep

Primary Outcome Measures

Name	Time	Method
Insomnia Symptoms	6 weeks	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

Secondary Outcome Measures

Name	Time	Method
Six Week Change in Sleep Efficiency	6 weeks	Sleep efficiency is calculated by the total time sleeping over the total time in bed.
Six Week Change in Wake After Sleep Onset	6 weeks	Amount of time awake during the night
Six Week Change in Sleep Onset Latency	6 weeks	Time to fall asleep
Six Week Change in Total Sleep Time	6 weeks	Total time asleep