Breast Cancer Clinical Trial
mHealth for Breast Cancer Survivors With Insomnia
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.
Full 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.
Eligibility Criteria
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
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