Actively Recruiting
Wellness App for Sleep Disturbance in Hematological Cancer Patients
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-02-19
276
Participants Needed
3
Research Sites
192 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
A
Arizona State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Wellness App for Sleep Disturbance in Hematological Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-declared diagnosis of hematological cancer on stable maintenance management by treating physician or observation with no changes in disease-targeted medications for the past two weeks
- Not currently participating in a therapeutic pharmacologic clinical trial
- Not planning to receive an allogenic stem cell transplantation during the 20-week study period
- Score greater than 5 on Pittsburgh Sleep Quality Index
- Own a mobile smartphone (iPhone with iOS 14 or later or Android 6 or later) with active data or WiFi connection
- Willing to download two mobile apps
- Able to read and understand English
- 18 years of age or older
- Willing to be randomized
- Willing to drive to a nearby lab for three blood draws during the study over 20 weeks
- Taking sleep medications or over-the-counter sleep drugs/supplements fewer than 3 nights per week and willing to maintain or discontinue use as specified throughout the study
You will not qualify if you...
- Regular meditation or meditative movement practice (yoga, tai chi, qi gong) of 60 minutes or more per week in the past 2 months
- Reside outside of the United States
- Planned change to a new pharmacologic therapy for cancer during the study period (excluding dose changes)
- Diagnosed with a sleep disorder other than insomnia (2 or more positive categories on Berlin Questionnaire)
- Taking prescribed or over-the-counter sleep medications or supplements 3 or more nights per week
- Any other diagnosed and uncontrolled medical or psychiatric condition
- Has a pacemaker
- Works a shift schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Arizona State University
Phoenix, Arizona, United States, 85004
Active, Not Recruiting
2
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27101
Actively Recruiting
3
Mays Cancer Center at The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
J
Jillian Johnson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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