Clinical trial · Interventional
Wellness App for Sleep Disturbance in Hematological Cancer Patients
Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients
- 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)
In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The investigators will recruit a total of 276 self-declared Chronic Hematological Cancer (CHC) patients who (representative of age, race/ethnicity, and gender) will be on stable CHC pharmacologic therapy (if any), self-identify as sleep disturbed (\>5 on Pittsburgh Sleep Quality Index), do not have a sleep disorder diagnosis, do not take sleep medication/supplements \>3 times per week, and are not currently practicing regular meditation. Aim 1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary)) and secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy. Aim 2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®). Aim 3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) in CHC patients.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wellness app intervention #1 | Behavioral | — | UNRESOLVED |
| Wellness app intervention #2 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Wellness app intervention #1
- description
- Participants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app.
- interventionNames
- Behavioral: Wellness app intervention #1
- type
- ACTIVE_COMPARATOR
- label
- Wellness app intervention #2
- description
- Participants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app.
- interventionNames
- Behavioral: Wellness app intervention #2
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Self-declared diagnosis of hematological cancer on stable maintenance management\* by treating physician (i.e., on stable medical therapy) or observation (i.e., no changes in disease targeted medications for the past two weeks) 2. Not currently participating in a therapeutic pharmacologic clinical trial 3. Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks) 4. Score of \>5 on PSQI (Pittsburgh Sleep Quality Index) 5. Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection 6. Willing to download two mobile apps 7. Able to read/understand English 8. ≥18 years of age 9. Willing to be randomized 10. Willing to drive to a nearby lab for blood draws 3x during the study over the course of 20 weeks (8-week intervention period followed by 12-week follow-up period) 11. Taking sleep medications and/or over-the-counter sleep drugs/supplements (if any) on fewer than 3 nights per week and one of the following: 1) willing to maintain the same intake without change throughout the study time frame (i.e., 20 weeks) or 2) willing to discontinue if intake is prescribed "as needed" (PRN) by a physician throughout the study time frame (i.e., 20 weeks) Exclusion Criteria: 1. Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months 2. Reside outside of the United States of America 3. Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes) 4. Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire) 5. Taking prescribed sleep medications and/or over-the-counter drugs/supplements (including drugs like NyQuil, Benadryl, and other antihistamine-based drugs) on ≥3 nights per week 6. Any other diagnosed and uncontrolled medical or psychiatric condition 7. Has a pacemaker 8. Shift work schedule
References
Publications (1)
- DERIVEDHuberty J, Bhuiyan N, Eckert R, Larkey L, Petrov M, Todd M, Mesa R. Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance. JMIR Res Protoc. 2022 Jul 1;11(7):e39007. doi: 10.2196/39007. PMID 35776489