Clinical trial · Interventional
Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
NCT04827459CI-TRIAL-00061883completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Insomnia | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sleep Coach App | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MI Sleep Coach Mobile Application
- 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.
- interventionNames
- Behavioral: Sleep Coach App
Primary outcomes (3)
- measure
- Percentage of participants engaging with the app at least 4 days/week
- timeFrame
- 7 weeks
- 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.
- measure
- Percentage of participants that find the intervention useful
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDArring 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 38669678