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Behavioural Intervention

Virtual Assistant for Insomnia in Breast Cancer Survivors

N/A

Recruiting

Led By Kerryn Reding

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, indicating ability to perform activities of daily living

Willing and able to complete the intervention with personal smartphone

Must not have

Previously received CBTi therapy with a professional therapist

Actively receiving chemotherapy or radiation (endocrine therapy permitted)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 0, 6 and 12

Awards & highlights

No Placebo-Only Group

Summary

"This trial examines the impact of a virtual assistant named Cecebot on improving insomnia in breast cancer survivors. Insomnia is a common issue among these survivors and can affect their quality of life. The virtual

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects might include discomfort from increased physical activity or stress from engaging with technology. However, as this is not a drug trial, severe side effects are less likely compared to medication trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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I can participate using my smartphone.

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I have severe insomnia symptoms.

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I am female.

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I was previously diagnosed with stage I-III breast cancer.

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I am 18 years old or older.

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I have had trouble sleeping for 3 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have undergone CBTi therapy with a professional.

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I am currently undergoing chemotherapy or radiation.

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

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I have been diagnosed with a sleep-related movement disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 0, 6 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 0, 6 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 0, 6 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment discontinuation rate

Secondary study objectives

AE rate

Adherence to physical activity (PA) recommendation

Adherence to sleep recommendations

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: GROUP II (waitlist control, Cecebot intervention)Experimental Treatment5 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 Treatment5 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavior Therapy for Insomnia

2017

N/A

~50

0 / 11Eligibility criteria met