Status:
COMPLETED
Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Insomnia
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial will evaluate the adherence, usefulness, satisfaction and effect size for the Sleep Coach app as an intervention for insomnia in 30 adult post-treatment cancer survivors.
Detailed Description
Difficulty sleeping, falling and/or staying asleep, is common in people after they have been diagnosed and treated for cancer. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered to be the...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Has completed curative-intent treatment (chemo, surgery, RT) for prostate, colon or breast cancer at least three months and not more than 5 years prior to study entry. Note: Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex), Herceptin and maintenance therapies are allowed.
- Ability to read and write English
- Ability to complete questionnaire(s) by themselves or with assistance.
- Reports trouble falling asleep or staying asleep on at least 3 nights per week (most weeks) for the last 3 months.
- Own an Android phone version 8 or higher (The latest version of Android is 11.0) or an iPhone running iOS 11 or higher (The latest version of iOS is 14.3.)
- Ability to provide informed written consent.
Exclusion
- Inability to read and write English
- Diagnosis of a sleep disorder other than insomnia (e.g. sleep apnea, restless legs syndrome, narcolepsy)
- Diagnosis of Insomnia prior to cancer diagnosis
- Reports physical symptoms that interfere with sleep, such as shortness of breath, pain, hot flashes, frequent urination
- Major psychiatric or medical condition other than cancer suspected to contribute to their sleep disturbance
- Evidence of active cancer (i.e. not considered NED)
- Currently or previously received CBT-I
- Patients who are night shift workers or subject to other external restrictions on their opportunity to sleep at night.
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04827459
Start Date
May 12 2021
End Date
August 8 2022
Last Update
November 2 2022
Active Locations (1)
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1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109