mHealth for Breast Cancer Survivors With Insomnia

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

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.

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.

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