Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedStudy Start
First participant enrolled
May 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2022
CompletedNovember 2, 2022
November 1, 2022
1.2 years
March 29, 2021
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Effect size of the intervention as measured by the Insomnia Severity Index (ISI).
baseline to 7 weeks
Study Arms (1)
MI Sleep Coach Mobile Application
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Arring N, Barton DL, Lafferty C, Cox B, Conroy DA, An L. Mi Sleep Coach Mobile App to Address Insomnia Symptoms Among Cancer Survivors: Single-Arm Feasibility Study. JMIR Form Res. 2024 Apr 26;8:e55402. doi: 10.2196/55402.
PMID: 38669678DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noel Arring, DNP, PhD, RN
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 1, 2021
Study Start
May 12, 2021
Primary Completion
August 8, 2022
Study Completion
August 8, 2022
Last Updated
November 2, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share