Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT04827459|
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Breast Cancer Prostate Cancer Colon Cancer||Behavioral: Sleep Coach App||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors|
|Actual Study Start Date :||May 12, 2021|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
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 Name: MI Sleep Coach
- Percentage of participants engaging with the app at least 4 days/week [ Time Frame: 7 weeks ]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 [ Time Frame: 7 weeks ]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 [ Time Frame: 7 weeks ]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.
- Effect size of the intervention as measured by the Insomnia Severity Index (ISI). [ Time Frame: baseline to 7 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827459
|United States, Michigan|
|University of Michigan Rogel Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Cancer AnswerLine 800-865-1125 CancerAnswerLine@med.umich.edu|
|Principal Investigator: Noel Arring, DNP, PhD, RN|
|Principal Investigator:||Noel Arring, DNP, PhD, RN||University of Michigan|