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

Primary Purpose

Insomnia, Breast Cancer, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Coach App
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Insomnia focused on measuring cancer survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Rogel Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MI Sleep Coach Mobile Application

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 29, 2021
Last Updated
November 1, 2022
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Breast Cancer Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04827459
Brief Title
Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
Official Title
Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Breast Cancer Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Breast Cancer, Prostate Cancer, Colon Cancer
Keywords
cancer survivor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MI Sleep Coach Mobile Application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Coach App
Other Intervention Name(s)
MI Sleep Coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants engaging with the app at least 4 days/week
Description
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.
Time Frame
7 weeks
Title
Percentage of participants that find the intervention useful
Description
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.
Time Frame
7 weeks
Title
Percentage of participants satisfied with the intervention
Description
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.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Effect size of the intervention as measured by the Insomnia Severity Index (ISI).
Description
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.
Time Frame
baseline to 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Arring, DNP, PhD, RN
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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