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Behavioral Intervention
mHealth Technology for Insomnia in Breast Cancer Survivors
N/A
Recruiting
Led By Hannah Arem, PhD
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial will determine if voice-activated smart speakers can help reduce insomnia symptoms in breast cancer survivors.
Who is the study for?
This trial is for female breast cancer survivors, aged 18 or older, who have finished their main treatments over 3 months ago and are experiencing insomnia. They should not have had other sleep treatments in the past year and must be able to speak English. Those with severe mental health issues, substance abuse history, shift work patterns, or certain untreated sleep disorders cannot join.Check my eligibility
What is being tested?
The study tests a website and smart speaker program designed to help with insomnia using Cognitive Behavioral Therapy for Insomnia (CBT-I) techniques. Participants will be randomly assigned to use these digital tools to see if they improve sleep quality among those who've survived breast cancer.See study design
What are the potential side effects?
Since this trial involves behavioral therapy through digital platforms rather than medication, there are no direct physical side effects expected from participating. However, participants may experience changes in their sleeping patterns as they adjust to the therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with breast cancer at stage I-III or IV but can still perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Symptoms
Secondary outcome measures
Sleep efficiency
Sleep onset latency
Total sleep time
+1 moreOther outcome measures
Sleep quality
System usability scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Voice-Activated Smart Speaker ProgramExperimental Treatment1 Intervention
Faster Asleep
Group II: WebsiteActive Control1 Intervention
Faster Asleep Website
Find a Location
Who is running the clinical trial?
Medstar Health Research InstituteLead Sponsor
191 Previous Clinical Trials
117,542 Total Patients Enrolled
Media RezUNKNOWN
1 Previous Clinical Trials
300 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,080 Previous Clinical Trials
340,854 Total Patients Enrolled
6 Trials studying Insomnia
488 Patients Enrolled for Insomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with bipolar disorder or schizophrenia, started therapy within the past three months, or had issues with alcohol or drug abuse in the past year. (Having moderate ADHD, depression, or anxiety is not a reason to be excluded.)I haven't had any sleep treatments in the last year.You have worked night shifts in the last three months or expect to work them during the study.You have an Insomnia Severity Index score of 8 or more.I am a woman aged 18 or older.I finished my cancer treatment aimed at curing it more than 3 months ago.I plan to travel out of my time zone for more than an hour during the study.I have been diagnosed with a sleep disorder but haven't received treatment.I have been diagnosed with breast cancer at stage I-III or IV but can still perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Voice-Activated Smart Speaker Program
- Group 2: Website
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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