Breast Cancer Survivor, Insomnia
Conditions
Keywords
Breast Cancer Survivor, Insomnia, mHealth, Digital Health, Cognitive Behavioral Therapy for Insomnia (CBT-I)
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.
Interventions
BEHAVIORALFaster 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.
BEHAVIORALFaster 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.
Sponsors
Media Rez
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Symptoms | 6 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Week Change in Sleep Efficiency | 6 weeks | Sleep efficiency is calculated by the total time sleeping over the total time in bed. |
| Six Week Change in Wake After Sleep Onset | 6 weeks | Amount of time awake during the night |
| Six Week Change in Sleep Onset Latency | 6 weeks | Time to fall asleep |
| Six Week Change in Total Sleep Time | 6 weeks | Total time asleep |
Other
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale | 6 weeks | 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. |
| End of Study Self-reported Sleep Quality | 6 weeks | 5-item Likert scale from Very Poor (5) to Very Good (1). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 38 |
| Total | 76 |
Baseline characteristics
| Characteristic | Website | Total | Voice-Activated Smart Speaker Program |
|---|---|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 8.7 | 61.2 years STANDARD_DEVIATION 9.3 | 62.6 years STANDARD_DEVIATION 9.8 |
| BMI | 25.6 kg/m2 | 25.8 kg/m2 | 25.9 kg/m2 |
| Education College Degree | 16 Participants | 30 Participants | 14 Participants |
| Education Graduate Degree | 18 Participants | 36 Participants | 18 Participants |
| Education High school/GED/Some college | 4 Participants | 10 Participants | 6 Participants |
| Employment Full Time | 16 Participants | 29 Participants | 13 Participants |
| Employment Part time | 7 Participants | 11 Participants | 4 Participants |
| Employment Retired | 15 Participants | 31 Participants | 16 Participants |
| Employment Unemployed | 0 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 74 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital status Divorced or separated | 5 Participants | 10 Participants | 5 Participants |
| Marital status Married or partnered | 24 Participants | 49 Participants | 25 Participants |
| Marital status Single | 7 Participants | 13 Participants | 6 Participants |
| Marital status Widowed | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 53 Participants | 28 Participants |
| Region of Enrollment United States | 38 participants | 76 participants | 38 participants |
| Sex: Female, Male Female | 38 Participants | 76 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| TNM Cancer Stage at diagnosis Stage 0 | 2 Participants | 2 Participants | 0 Participants |
| TNM Cancer Stage at diagnosis Stage 1 | 12 Participants | 33 Participants | 21 Participants |
| TNM Cancer Stage at diagnosis Stage 2 | 17 Participants | 29 Participants | 12 Participants |
| TNM Cancer Stage at diagnosis Stage 3 | 5 Participants | 8 Participants | 3 Participants |
| TNM Cancer Stage at diagnosis Stage 4 | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
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
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voice-Activated Smart Speaker Program | Insomnia Symptoms | -8.4 units on a scale | Standard Deviation 4.7 |
| Website | Insomnia Symptoms | -2.6 units on a scale | Standard Deviation 3.5 |
p-value: <0.0595% CI: [3.84, 7.81]Mixed Models Analysis
Secondary
Six Week Change in Sleep Efficiency
Sleep efficiency is calculated by the total time sleeping over the total time in bed.
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Voice-Activated Smart Speaker Program | Six Week Change in Sleep Efficiency | 0.09 proportion of time asleep/time in bed |
| Website | Six Week Change in Sleep Efficiency | 0.05 proportion of time asleep/time in bed |
Secondary
Six Week Change in Sleep Onset Latency
Time to fall asleep
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Voice-Activated Smart Speaker Program | Six Week Change in Sleep Onset Latency | -13.79 minutes |
| Website | Six Week Change in Sleep Onset Latency | -5.46 minutes |
Secondary
Six Week Change in Total Sleep Time
Total time asleep
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Voice-Activated Smart Speaker Program | Six Week Change in Total Sleep Time | 0.26 hours |
| Website | Six Week Change in Total Sleep Time | 0.27 hours |
Secondary
Six Week Change in Wake After Sleep Onset
Amount of time awake during the night
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Voice-Activated Smart Speaker Program | Six Week Change in Wake After Sleep Onset | -18.6 minutes |
| Website | Six Week Change in Wake After Sleep Onset | -9.1 minutes |
Other Pre-specified
End of Study Self-reported Sleep Quality
5-item Likert scale from Very Poor (5) to Very Good (1).
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voice-Activated Smart Speaker Program | End of Study Self-reported Sleep Quality | 2.44 score on a scale | Standard Deviation 0.08 |
| Website | End of Study Self-reported Sleep Quality | 3.03 score on a scale | Standard Deviation 0.08 |
Other Pre-specified
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.
Time frame: 6 weeks
Population: intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voice-Activated Smart Speaker Program | System Usability Scale | 72.2 score on a scale | Standard Deviation 16.6 |
| Website | System Usability Scale | 50.79 score on a scale | Standard Deviation 15.9 |