Clinical trial NCT05233800: mHealth for Breast Cancer Survivors With Insomnia
Official title: Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivor
Insomnia
Keywords: Breast Cancer Survivor
Insomnia
mHealth
Digital Health
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Media Rez
First posted: 2022-02-10
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Insomnia Symptoms
timeFrame: 6 weeks
Secondary outcomes:
measure: Six Week Change in Sleep Efficiency
timeFrame: 6 weeks
measure: Six Week Change in Wake After Sleep Onset
timeFrame: 6 weeks
measure: Six Week Change in Sleep Onset Latency
timeFrame: 6 weeks
measure: Six Week Change in Total Sleep Time
timeFrame: 6 weeks
Other outcomes:
measure: System Usability Scale
timeFrame: 6 weeks
measure: End of Study Self-reported Sleep Quality
timeFrame: 6 weeks
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Hannah Arem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Starling 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.