Trial Outcomes & Findings for mHealth for Breast Cancer Survivors With Insomnia (NCT NCT05233800)

Last Updated: 2025-01-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	Voice-Activated Smart Speaker Program Faster Asleep 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.	Website Faster Asleep Website 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.
Overall Study STARTED	38	38
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

mHealth for Breast Cancer Survivors With Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voice-Activated Smart Speaker Program n=38 Participants Faster Asleep 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.	Website n=38 Participants Faster Asleep Website 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.	Total n=76 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	59.8 years STANDARD_DEVIATION 8.7 • n=7 Participants	61.2 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	38 participants n=7 Participants	76 participants n=5 Participants
Marital status Single	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Marital status Married or partnered	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Marital status Divorced or separated	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Marital status Widowed	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Employment Full Time	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Employment Part time	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Employment Retired	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Employment Unemployed	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Education High school/GED/Some college	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Education College Degree	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Education Graduate Degree	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
TNM Cancer Stage at diagnosis Stage 0	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
TNM Cancer Stage at diagnosis Stage 1	21 Participants n=5 Participants	12 Participants n=7 Participants	33 Participants n=5 Participants
TNM Cancer Stage at diagnosis Stage 2	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
TNM Cancer Stage at diagnosis Stage 3	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
TNM Cancer Stage at diagnosis Stage 4	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
BMI	25.9 kg/m2 n=5 Participants	25.6 kg/m2 n=7 Participants	25.8 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Intent to treat

Outcome measures

Outcome measures
Measure	Voice-Activated Smart Speaker Program n=35 Participants Faster Asleep 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.	Website n=35 Participants Faster Asleep Website 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.
Insomnia Symptoms	-8.4 units on a scale Standard Deviation 4.7	-2.6 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 6 weeks

Population: Intent to treat

Sleep efficiency is calculated by the total time sleeping over the total time in bed.

Outcome measures

Outcome measures
Measure	Voice-Activated Smart Speaker Program n=35 Participants Faster Asleep 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.	Website n=35 Participants Faster Asleep Website 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.
Six Week Change in Sleep Efficiency	0.09 proportion of time asleep/time in bed Interval 0.07 to 0.11	0.05 proportion of time asleep/time in bed Interval 0.03 to 0.07

SECONDARY outcome

Timeframe: 6 weeks

Population: Intent to treat

Amount of time awake during the night

Outcome measures

Outcome measures
Measure	Voice-Activated Smart Speaker Program n=35 Participants Faster Asleep 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.	Website n=35 Participants Faster Asleep Website 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.
Six Week Change in Wake After Sleep Onset	-18.6 minutes Interval -23.9 to -13.36	-9.1 minutes Interval -14.6 to -3.63

SECONDARY outcome

Timeframe: 6 weeks

Population: Intent to treat

Time to fall asleep

Outcome measures

Outcome measures
Measure	Voice-Activated Smart Speaker Program n=35 Participants Faster Asleep 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.	Website n=35 Participants Faster Asleep Website 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.
Six Week Change in Sleep Onset Latency	-13.79 minutes Interval -18.2 to -9.33	-5.46 minutes Interval -10.1 to -0.86

SECONDARY outcome

Timeframe: 6 weeks

Population: Intent to treat

Total time asleep

Outcome measures

Outcome measures
Measure	Voice-Activated Smart Speaker Program n=35 Participants Faster Asleep 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.	Website n=35 Participants Faster Asleep Website 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.
Six Week Change in Total Sleep Time	0.26 hours Interval 0.06 to 0.45	0.27 hours Interval 0.06 to 0.47

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: intent to treat

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.

Outcome measures

Outcome measures
Measure	Voice-Activated Smart Speaker Program n=35 Participants Faster Asleep 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.	Website n=35 Participants Faster Asleep Website 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.
System Usability Scale	72.2 score on a scale Standard Deviation 16.6	50.79 score on a scale Standard Deviation 15.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: Intent to treat

5-item Likert scale from Very Poor (5) to Very Good (1).

Outcome measures

Outcome measures
Measure	Voice-Activated Smart Speaker Program n=35 Participants Faster Asleep 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.	Website n=35 Participants Faster Asleep Website 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.
End of Study Self-reported Sleep Quality	2.44 score on a scale Standard Deviation 0.08	3.03 score on a scale Standard Deviation 0.08

Adverse Events

Voice-Activated Smart Speaker Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Website

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hannah Arem, Scientific Director, Implementation Science

MedStar Health Research Institute

Phone: 2028932430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place