mHealth for Breast Cancer Survivors With Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233800
• Other study ID #: 4298
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: March 2024

Study information

• Verified date: June 2023
• Source: Medstar Health Research Institute
• Contact: Hannah Arem, PhD
• Phone: 202-893-2430
• Email: Hannah.Arem[@]MedStar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Survivor
• Breast Neoplasms
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Media Rez

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	System usability scale	A 10-item scale on general usability of technology. This provides a score of 0-100, with above 68 indicating better than average usability, where higher is better. This is a normalized score and not a percentage.	6 weeks
Other	Sleep quality	5-item Likert scale from Very Poor to Very Good.	6 weeks
Primary	Insomnia Symptoms	Data will be collected on the Insomnia Severity Index (ISI) total score pre- and post-intervention as our primary outcome. The ISI is a seven-item questionnaire with response categories from 0-4 (total score 0-28) asking about sleep patterns and specifically characterizing insomnia over the two weeks prior. The ISI defines 'no clinically significant' insomnia as a score of 0-7, 'sub-threshold' insomnia as a score of 8-14, 'moderate severity clinical' insomnia' a scores of 15-21, and 'severe clinical' insomnia as a score of 22-28. Clinically relevant target for success is to achieve sub-threshold or better scores (=14) among >80% of the intervention participants	6 weeks
Secondary	Sleep efficiency	Sleep efficiency is calculated by the total time sleeping over the total time in bed.	6 weeks
Secondary	Wake after sleep onset	Amount of time awake during the night	6 weeks
Secondary	Sleep onset latency	Time to fall asleep	6 weeks
Secondary	Total sleep time	Total time asleep	6 weeks