Wellness App for Sleep Disturbance in Hematological Cancer Patients (NCT05294991)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (9 items).
Location: Arizona State University — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
- 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
- Any other diagnosed and uncontrolled medical or psychiatric condition
- Has a pacemaker
- Shift work schedule
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Arizona State University — Phoenix, Arizona
- Wake Forest University School of Medicine — Winston-Salem, North Carolina
- Mays Cancer Center at The University of Texas Health Science Center at San Antonio — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.