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

Trial Summary

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 data supports the effectiveness of the treatment Cecebot, a virtual assistant for insomnia in breast cancer survivors?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), which is part of Cecebot's approach, is effective for improving sleep in breast cancer survivors. A study found that eHealth CBT-I led to significant improvements in insomnia symptoms, sleep disturbance, and sleep efficiency among Spanish-speaking breast cancer survivors. ^{1 2 3 4 5}

Is the Virtual Assistant for Insomnia in Breast Cancer Survivors safe for humans?

The studies on cognitive behavioral therapy for insomnia (CBT-I), including digital and telemedicine versions, show that it is generally safe and well-accepted by participants, with high satisfaction and retention rates. ^{1 2 4 5 6}

How is the treatment Cecebot different from other insomnia treatments for breast cancer survivors?

Cecebot is unique because it uses a virtual assistant to deliver cognitive behavioral therapy for insomnia (CBT-I) through SMS, making it more accessible and convenient compared to traditional in-person therapy sessions. ^{2 4 5 7 8}

What is the purpose of this trial?

This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ranks among the top concerns reported by breast cancer survivors and is associated with poor quality of life. Many breast cancer survivors also have decreased physical activity, which may also have a negative impact on sleep and quality of life. Cognitive behavioral therapy for insomnia (CBTi) and physical activity interventions have individually been reported to improve sleep and to have a positive impact on quality of life. Cecebot is a personalized short messaging service (SMS)-based behavioral intervention that combines CBTi and physical activity strategies that may improve sleep for breast cancer survivors.

Research Team

Kerryn Reding

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Telemedicine-Delivered Cognitive Behavioral Therapy for Insomnia in Rural Breast Cancer Survivors. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Does expectancy affect insomnia treatment response in cancer survivors receiving acupuncture and cognitive behavioral therapy? [2023]

4. England 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. [2022]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive behavioral therapy for insomnia in breast cancer: A meta-analysis. [2022]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Smartphone apps for insomnia: examining existing apps' usability and adherence to evidence-based principles for insomnia management. [2019]