Wellness App for Sleep Disturbance in Hematological Cancer Patients

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.

NCT Number	NCT05294991
Lead Sponsor	The University of Texas Health Science Center at San Antonio Collaborators: Arizona State University, Laboratory Corporation of America, Wake Forest University Health Sciences, Calm.com, Inc., National Cancer Institute (NCI)
Conditions	Cancer, Sleep Disturbance, Anxiety, Depression, Inflammation, Fatigue
Enrollment	276 participants
Start Date	2023-02-20
Primary Completion	2026-12-20 (estimated)
Study Completion	2026-12-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-05