Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827459
• Other study ID #: UMCC 2021.004
• Secondary ID: HUM00194610
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: November 2022
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 preferred treatment but until now, there has been limited access for most people to CBT-I because it has required an in-person visit with a trained therapist. This research study is to test a mobile CBT-I app called MI Sleep Coach to deliver CBT-I. The goal of this study is to understand if people are willing to use the app, if they find it useful in helping with sleep difficulty and if they are satisfied with using it. The investigators hope to use information from this small feasibility study to study the effectiveness of the app in a larger group of cancer survivors and ultimately to help cancer survivors with sleep difficulties to sleep better.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Insomnia
• Prostate Cancer
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Sleep Coach App
Participants will be encouraged to interact with the mobile app daily for as much time as they wish, or for as little as 5 - 10 minutes, over a 7-week period.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants engaging with the app at least 4 days/week	Adherence will be evaluated using data gathered from the application. Participants will be asked to interact daily with the application and will be deemed adherent if they interact with the app at least 4 times per week for the duration (7 weeks) of the study. Adherence rate will be the number of participants deemed adherent / total number of participants.	7 weeks
Primary	Percentage of participants that find the intervention useful	Usefulness will be assessed using a survey developed by the investigators of this study called the User Experience Survey, which is based upon the Unified Theory of Acceptance and Use of Technology (UTAUT). The survey assesses perceived ease of use and usefulness of the Sleep Coach app as well as participant satisfaction with the app. To assess usefulness, participants are asked to rate the usefulness of 10 different features of the Sleep Coach app on a scale of 1 to 4, with higher scores indicating greater usefulness. Participants who rate at least one app feature 2 or greater will be considered as finding the intervention useful.	7 weeks
Primary	Percentage of participants satisfied with the intervention	Satisfaction will be assessed using 2 questions from the User Experience Survey: one to determine the level of overall satisfaction with the app and the other to determine the level of willingness to recommend the app to others. Satisfaction questions are rated on a scale of 1 to 5, with higher scores indicating greater agreement/satisfaction. Participants who rate both questions 4 or greater will be considered satisfied with the Sleep Coach app.	7 weeks
Secondary	Effect size of the intervention as measured by the Insomnia Severity Index (ISI).	The ISI is a 7-item questionnaire used to measure a patient's perceptions of the nature, impact and severity of insomnia. Items are scored on a scale of 0 to 4, with higher scores indicating more severe insomnia. Cohen's d or f will be calculated from baseline to week 7 to assess the effect size of the intervention.	baseline to 7 weeks