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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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment discontinuation rate
Secondary outcome measures
AE rate
Adherence to physical activity (PA) recommendation
Adherence to sleep recommendations
+7 more

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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavior Therapy for Insomnia
2017
N/A
~50

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,905,446 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
The Hope FoundationUNKNOWN
Kerryn RedingPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
17 Total Patients Enrolled
~40 spots leftby Dec 2024
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