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Evaluation of Smartphone Wellness Apps for the Management of Sleep Disturbances in Patients with a Hematological Cancer
Trial Status: active
This clinical trial compares two different smartphone wellness applications (apps) for the management of sleep disturbances in patients with a hematological cancer. Sleep disturbances, or trouble sleeping, is a common problem that many chronic hematological cancer (CHC) patients have. Sleep disturbances are associated with poorer cognitive and physical functioning, increase in fatigue and emotional distress, and heightened levels of specific inflammatory markers that negatively impact quality of life. However, there is evidence to suggest that various lifestyle modifications and behaviors can positively impact sleep in CHC patients, including mindfulness-based interventions. Smartphone apps have attracted considerable interest from cancer patients as an easily accessible and empowering way to self-manage health. The researchers hope to learn what the potential benefits of two different app-based interventions for sleep disturbances are on CHC patients undergoing treatment.
Inclusion Criteria
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)
* Chronic hematological cancer sub-types include chronic lymphocytic leukemia, follicular lymphoma, smoldering myeloma, myeloma, myeloproliferative neoplasm sub-types (polycythemia vera, essential thrombocythemia, myelofibrosis), systemic mastocytosis, chronic myelomonocytic leukemia, myelodysplastic syndrome
Not currently participating in a therapeutic pharmacologic clinical trial
Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks)
Score of > 5 on PSQI (Pittsburgh Sleep Quality Index)
Own a mobile smartphone (iPhone with iPhone operating system [iOS] 14 or later or an Android 6 or later) with an active data or WiFi connection
Willing to download two mobile apps
Able to read/understand English
>= 18 years of age
Willing to be randomized
Willing to drive to a nearby lab for blood draws 3x during the study over the course of 21 weeks (8-week intervention period followed by 12-week follow-up period)
Taking prescribed 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
Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of >= 60 min/week in past 2 months
Reside outside of the United States of America
Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes)
Diagnosed with a sleep disorder except insomnia (>= 2 positive categories on Berlin Questionnaire using modified scoring)
Taking prescribed sleep medications and/or over-the-counter drugs/supplements on ≥ 3 nights per week (including drugs like NyQuil, Benadryl, and other antihistamine-based drugs)
Any other diagnosed and uncontrolled medical or psychiatric condition
Has a pacemaker
Shift work schedule
Additional locations may be listed on ClinicalTrials.gov for NCT05294991.
I. Test the efficacy of daily meditation (10 minutes/day) delivered via Calm compared to podcast control group (POD) on the primary outcome of self-reported sleep disturbance (Insomnia Severity Index [primary] and Patient-Reported Outcomes Measurement Information System [PROMIS] Sleep Disturbance Short Form 8b [secondary]) and additional secondary sleep outcomes including sleep impairment (PROMIS Sleep-Related Impairment Short Form 8a) and sleep efficiency measured via sleep diaries and actigraphy.
II. Test the efficacy of daily meditation (10 minutes/day) delivered via Calm compared to POD on inflammatory markers (i.e., tumor necrosis factor alpha [TNF-alpha], interleukin (IL)-6, IL-8, c-reactive protein [CRP]), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS).
III. Explore the sustained effects (i.e., 20 weeks from baseline) of Calm compared to POD in chronic hematological cancer (CHC) patients.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients practice meditation via the Calm smartphone app at least 10 minutes once daily (QD) for 8 weeks. Patients also complete the introductory 30-day program “How to Meditate” during weeks 1-4. Patients receive automated email or text message reminders weekly to encourage continued participation. Patients also wear an Oura Ring for 20 weeks. Patients undergo blood sample collection throughout the trial.
ARM II: Patients listen to health education podcasts via the POD smartphone app at least 10 minutes QD for 8 weeks. Patients receive automated email or text message reminders weekly to encourage continued participation. Patients also wear an Oura Ring for 20 weeks. Patients undergo blood sample collection throughout the trial.
After completion of study intervention, patients are followed up to 12 weeks (20 weeks from baseline).
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
