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RECRUITING

NCT05294991

Wellness App for Sleep Disturbance in Hematological Cancer Patients

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

Summary

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.

Official title: Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2023-02-20

Completion Date

2026-10-31

Last Updated

2026-02-19

Healthy Volunteers

Conditions

Cancer Sleep Disturbance Anxiety Depression Inflammation Fatigue

Interventions

BEHAVIORAL

Wellness app intervention #1

This is the active intervention group.

BEHAVIORAL

Wellness app intervention #2

This is the active comparator/control group.

Inclusion Criteria: 1. 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) 2. Not currently participating in a therapeutic pharmacologic clinical trial 3. Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks) 4. Score of \>5 on PSQI (Pittsburgh Sleep Quality Index) 5. Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection 6. Willing to download two mobile apps 7. Able to read/understand English 8. ≥18 years of age 9. Willing to be randomized 10. Willing to drive to a nearby lab for blood draws 3x during the study over the course of 20 weeks (8-week intervention period followed by 12-week follow-up period) 11. Taking 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: 1. Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months 2. Reside outside of the United States of America 3. Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes) 4. Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire) 5. 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 6. Any other diagnosed and uncontrolled medical or psychiatric condition 7. Has a pacemaker 8. Shift work schedule

Locations (3)

Arizona State University

Phoenix, Arizona, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Mays Cancer Center at The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States