mHealth for Breast Cancer Survivors With Insomnia

MedStar Health

Status: Completed

Conditions: Breast Cancer Survivor; Insomnia

Treatments: Behavioral: Faster Asleep Website; Behavioral: Faster Asleep Smart Speaker Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05233800

4298

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Voice-Activated Smart Speaker Program

Experimental group

Description:

Faster Asleep

Treatment:

Behavioral: Faster Asleep Smart Speaker Program

Website

Active Comparator group

Description:

Faster Asleep Website

Treatment:

Behavioral: Faster Asleep Website