Virtual Assistant for Insomnia in Breast Cancer Survivors

Overseen By Julia Kristoferson Palmer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Prescribed sleep medication

Disqualifiers: Sleep apnea, Shiftwork, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a virtual assistant, Cecebot, can improve sleep for women who have survived stage I-III breast cancer and are experiencing insomnia. It combines strategies from cognitive behavioral therapy and physical activity to enhance sleep quality and life satisfaction. Participants will receive messages and guidance on their phones to help manage sleep issues. This trial suits women with a history of stage I-III breast cancer who have experienced insomnia for at least three months and own a smartphone. As an unphased study, the trial offers a unique opportunity to explore innovative solutions for improving sleep and quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who use prescribed sleep medication more than 3 times a week.

What prior data suggests that Cecebot is safe for breast cancer survivors?

Research has shown that Cecebot's safety and ease of use have been studied before. Cecebot is a texting tool that combines sleep tips and exercise advice to help improve sleep. In past studies, users found Cecebot easy to use and generally well-received, with no major reports of negative side effects.

As a digital tool, Cecebot doesn't involve taking medicine or undergoing medical procedures, so the risk of physical side effects is low. However, some users might find it challenging to keep up with the texts or daily activity tracking, which are part of the program. Overall, existing evidence suggests that Cecebot is safe to use, especially since it serves as a supportive digital tool rather than a medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for insomnia in breast cancer survivors, which often involve medication or cognitive behavioral therapy, Cecebot is a virtual assistant that uses SMS conversations and online content to provide sleep education and support. Researchers are excited about this approach because it offers a non-pharmacological, easily accessible solution that patients can engage with regularly, potentially leading to improved sleep patterns. Additionally, Cecebot's integration with an activity tracker provides personalized insights and feedback, making it a unique tool that adapts to each user's progress over time.

What evidence suggests that Cecebot is effective for improving insomnia in breast cancer survivors?

Research has shown that cognitive behavioral therapy for insomnia (CBTi) helps breast cancer survivors sleep better and improve their quality of life. This trial tests Cecebot, a new treatment that combines CBTi with physical activity tips. Participants will receive personalized text messages from Cecebot to aid sleep improvement. Early results suggest that tools like Cecebot can help address sleep problems in breast cancer survivors. Although more research is needed, combining these proven methods offers a promising way to manage insomnia in this group. ^{2 3 4 5 6}

Who Is on the Research Team?

Kerryn Reding

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for stage I-III breast cancer survivors who are experiencing insomnia. It aims to help improve their sleep and quality of life by using a conversational agent called Cecebot, which provides support via text messages.

Inclusion Criteria

I can participate using my smartphone.

I have severe insomnia symptoms.

I am female.

Exclusion Criteria

I have undergone CBTi therapy with a professional.

Current shiftwork

I have sleep apnea, whether or not I'm being treated for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention (Group I)

Participants receive sleep education SMS conversations, access to website content modules, sleep compression SMS conversations, and wear an activity tracker daily

6 weeks

2-4 times per week (virtual)

Waitlist Control (Group II)

Participants receive sleep education SMS conversations, access to website content modules, sleep compression SMS conversations, and wear an activity tracker daily

6 weeks

2-4 times per week (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cecebot

Trial Overview The study tests the effectiveness of Cecebot in delivering cognitive behavioral therapy for insomnia (CBTi) and encouraging physical activity. Participants will also use medical devices, answer questionnaires, and may receive other internet-based interventions.

How Is the Trial Designed?

Group I: GROUP II (waitlist control, Cecebot intervention) Experimental Treatment 5 Interventions

Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.

Group II: GROUP I (Cecebot intervention) Experimental Treatment 5 Interventions

Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 1-6.

Cecebot is already approved in United States for the following indications:

Approved in United States as Cecebot for:

• Insomnia in Stage I-III Breast Cancer Survivors

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

The Hope Foundation

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

A 6-week randomized controlled trial will assess the effectiveness of voice-activated cognitive behavioral therapy for insomnia (CBT-I) in breast cancer survivors, who often experience insomnia at rates of 30-50%.

The study aims to compare the efficacy of this innovative delivery method against a sleep education control, with the primary outcome being the Insomnia Severity Index score, which will help determine if this approach can effectively reduce insomnia symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol. Starling, CM., Greenberg, D., Zhou, E., et al.[2022]

The study aims to evaluate the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) compared to sleep hygiene education (SHE) in 308 women with cancer experiencing insomnia, with assessments at 12 and 24 weeks.

The primary outcome will measure changes in sleep quality using the Sleep Condition Indicator (SCI) score, helping to determine if dCBT-I provides better management of insomnia than SHE in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Sleepio after cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. Treacy, T., O'Meara, Y., Galligan, MC., et al.[2023]

A pilot study involving 30 Spanish-speaking breast cancer survivors showed that a 6-week eHealth Cognitive-Behavioral Therapy for Insomnia (CBT-I) intervention was highly acceptable and feasible, with excellent recruitment (95%) and retention (97%).

Post-treatment results indicated that CBT-I significantly improved insomnia symptoms, sleep disturbance, and sleep efficiency, with medium to large effect sizes, demonstrating its preliminary efficacy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. Oswald, LB., Morales-Cruz, J., Eisel, SL., et al.[2023]

Out of 357 mobile health apps reviewed for insomnia, only 12 met the criteria for further evaluation, indicating a limited availability of evidence-based tools for managing insomnia.

The reviewed apps showed moderate adherence to cognitive behavioral therapy for insomnia (CBT-I) principles and usability, suggesting there is significant potential for improvement and development of more effective mHealth solutions for insomnia management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for insomnia: examining existing apps' usability and adherence to evidence-based principles for insomnia management. Yu, JS., Kuhn, E., Miller, KE., et al.[2019]

The Sleep Scholar intervention, a self-guided online program for insomnia, was found to be feasible and acceptable among college students with a history of suicidal ideation and insomnia symptoms, with 38 participants completing the study.

Participants reported positive satisfaction with the program, and post-treatment analyses indicated clinically significant reductions in mental health symptoms, suggesting potential benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of sleep scholar: A single-session, internet-based insomnia intervention for college students with a history of suicide ideation. Crosby Ms Msw, ES., Witte PhD, TK.[2023]

In a study of cancer survivors undergoing treatment for insomnia, higher pre-treatment expectations significantly predicted better outcomes for those receiving acupuncture, with a notable reduction in insomnia severity and a higher response rate (76% vs. 38%).

Conversely, pre-treatment expectancy did not significantly influence the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), suggesting that the mechanism of action may differ between these two non-pharmacological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does expectancy affect insomnia treatment response in cancer survivors receiving acupuncture and cognitive behavioral therapy? Li, X., Bao, T., Garland, SN., et al.[2023]

A nurse-led, telemedicine-delivered cognitive behavioral therapy for insomnia (CBTI) was found to be feasible and effective for improving sleep outcomes in 18 rural breast cancer survivors, with significant improvements in sleep efficiency and sleep latency after six weekly sessions.

Participants also reported enhanced quality of life and daily functioning, although levels of anxiety and depression did not show improvement, indicating that while CBTI can help with sleep, it may not address all mental health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Telemedicine-Delivered Cognitive Behavioral Therapy for Insomnia in Rural Breast Cancer Survivors. McCarthy, MS., Matthews, EE., Battaglia, C., et al.[2019]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in reducing insomnia and improving sleep quality in breast cancer survivors, with a significant pooled effect size of -0.779 based on 14 randomized controlled trials involving 1363 participants.

The benefits of CBT-I for insomnia persist over time, showing medium-to-large effect sizes at both short-term (within six months) and long-term (12 months) follow-ups, indicating its lasting impact on sleep quality for women treated for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive behavioral therapy for insomnia in breast cancer: A meta-analysis. Ma, Y., Hall, DL., Ngo, LH., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06392789

A Conversational Agent (Cecebot) to Improve Insomnia in ... This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40658949/?utm_source=SimplePie&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1bAXfGTh08tVk-e1kpwuqxoVfiUn_5olMN9ewCML2bdAMGPEOD&fc=20220524054416&ff=20250714192327&v=2.18.0.post9+e462414

Protocol for a Pilot Waitlist Randomized Controlled Trial A Personalized, Texting-Based Conversational Agent to Address Sleep Disturbance in Individuals Who Have Survived Breast Cancer: Protocol for a ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03110

A Conversational Agent (Cecebot) to Improve Insomnia in ... This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors.

4. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15067.a-conversational-agent-cecebot-to-improve-insomnia-in-stage-i-iii-breast-cancer-survivors.html

A Conversational Agent (Cecebot) to Improve Insomnia in ... This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors.

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074825004718

A Personalized, Texting-Based Conversational Agent to ... Cognitive behavioral therapy for insomnia (CBTi) has shown efficacy for improving sleep and QoL for this population. Considered the gold ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06392789

A Conversational Agent (Cecebot) to Improve Insomnia in ... This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ...