mHealth for Breast Cancer Survivors With Insomnia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2023-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Survivor Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Voice-Activated Smart Speaker Program

Faster Asleep

Group Type EXPERIMENTAL

Faster Asleep Smart Speaker Program

Intervention Type BEHAVIORAL

Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia.

Website

Faster Asleep Website

Group Type ACTIVE_COMPARATOR

Faster Asleep Website

Intervention Type BEHAVIORAL

Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program.

Interventions

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Faster Asleep Smart Speaker Program

Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia.

Intervention Type BEHAVIORAL

Faster Asleep Website

Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No