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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Insomnia; Prostate Cancer; Colon Cancer
• Intervention / Treatment: Behavioral: Sleep Coach App

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MI Sleep Coach Mobile Application; The Sleep Coach app includes evidence-based CBT-I strategies, interactive activities and a computerized dialogue agent to engage users in the adoption of and adherence to CBT-I strategies.	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.; Other Names: MI Sleep Coach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Breast Cancer Research Foundation
• Investigators: Principal Investigator: Noel Arring, DNP, PhD, RN, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: cancer survivor
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: UMCC 2021.004; HUM00194610 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No