InsomniaNCT04827459
Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
A study testing Sleep Coach App in people with Insomnia and Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Breast Cancer, Prostate Cancer
- What is being tested?
- Sleep Coach App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 8 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Insomnia, Breast Cancer, Prostate Cancer, Colon Cancer
- Being tested
- Sleep Coach App
- Keywords
- cancer survivor
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Breast Neoplasms, Prostatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Coach AppBehavioural
Also called MI Sleep Coach
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.
| Study group | Role | What they receive |
|---|---|---|
| MI Sleep Coach Mobile Application | Experimental | 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. Receives: Behavioral: Sleep Coach App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 7 weeks
Secondary outcomes (1)
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.
Measured: baseline to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start12 May 2021
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Noel Arring, DNP, PhD, RN, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827459
- Sponsor's protocol ID
- UMCC 2021.004
- Other IDs
- HUM00194610
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38669678
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT04827459
- Acronym / sponsor ID
- UMCC 2021.004
- Conditions
- Insomnia, Breast Cancer, Prostate Cancer, Colon Cancer
- Keywords
- cancer survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 12 May 2021 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI Sleep Coach Mobile Application | Experimental | Behavioral: Sleep Coach AppThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Coach AppAlso: MI Sleep CoachParticipants 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. | Behavioural | MI Sleep Coach Mobile Application |
Primary outcome
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.
1 secondary outcome
Effect size of the intervention as measured by the Insomnia Severity Index (ISI).
Time frame: baseline to 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 38669678Arring 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel Arring, DNP, PhD, RN principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Coach App in people with Insomnia and Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants engaging with the app at least 4 days/week (time frame: 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.