Clinical trial · Interventional
Calm for Cancer Sleep Disturbance
A Pilot Study of Calm for Cancer Patient Sleep Disturbance
- 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)
Cancer and cancer treatment often lead patients and survivors to experience a host of chronic symptoms, of which sleep disturbances are a major concern. Smartphone-based meditation via an already-developed app (i.e., Calm) is a unique and novel way of providing a potentially helpful symptom-management strategy to cancer patients and survivors. Our hypothesis is that cancer patients/survivors using the Calm smartphone app for eight weeks will see improved sleep disturbance (primary outcome) as well as anxiety, depression, pain intensity, global health, quality of life, emotional regulation, and mindfulness when compared to a time and attention-matched health education podcast control group. Cancer patients/survivors (n=300) will be randomly assigned to an intervention or control group for eight weeks, with study outcome measurement occurring at baseline, post-intervention (i.e., week eight), and follow-up (i.e., week 20).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calm Meditation Mobile App | Behavioral | — | UNRESOLVED |
| Health Education Podcast Mobile App | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Calm Meditation
- description
- The intervention will be 8-weeks in duration and will consist of a series of pre-approved meditation classes. Patients will be asked to participate in at least 10 min/day of meditation (i.e., \~70 min/week). Week 1-4 will consist of the "7 Days of Calm" followed by the "21 Days of Calm", which are introductory courses offered by Calm and provide basic, introductory meditation classes for beginners. Weeks 5-8 will consist of patients participating in the "Daily Calm" that Calm provides, consisting of 10-12 min meditation classes that have a unique focus each day. Patients will be instructed to participate in at least 10 min/day of meditation, but will be encouraged to do more if they can.
- interventionNames
- Behavioral: Calm Meditation Mobile App
- type
- ACTIVE_COMPARATOR
- label
- Health Education Podcast
- description
- The control group will serve as an active control group and will be matched for time and attention to the intervention group. Participants assigned to the control group will be asked to listen to/view 10-min/day (i.e., \~70 min/week) of health education podcasts via a smartphone app. Topics covered in the health education control vary and will be aimed at providing useful and informative health-related information pertinent to cancer patients. The podcast app was developed by an independent app developer, and it was designed to mirror the type of functionality that the Calm app offers its users.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a cancer diagnosis within the past 2 years * self-identify as sleep disturbed (Pittsburgh Sleep Quality Index score of \>5 indicating moderate sleep disturbance) * own a mobile smartphone (iPhone with iOS 9.0 or later or an Android 4.1 or later) * willing to download a mobile app * able to read and understand English * aged 18 years or older * willing to be randomized to one of two groups * no change in pharmacologic therapy over the past two weeks * no change in sleep medication use (if any) over the past six weeks Exclusion Criteria: * meditation or meditative movement practice (i.e., yoga, tai chi, qigong) of greater than or equal to 60 min/month in the past six months * use of any consumer-based meditation app * reside outside of the United States * any planned change in pharmacologic therapy or planned stem cell transplant during the study interval (i.e., 20 weeks) * self-reported sleep-disordered breathing and/or sleep movement disorder
References
Publications (0)
Data not yet available