RecruitingNot ApplicableNCT05294991

Wellness App for Sleep Disturbance in Hematological Cancer Patients

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


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

276 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a wellness smartphone app can improve sleep quality in people with blood cancers (hematological cancers) who are on stable treatment or observation. **You may be eligible if...** - You have been diagnosed with a blood cancer and are on stable maintenance treatment or being watched without medication changes for the past two weeks - You are experiencing sleep problems (score above 5 on the Pittsburgh Sleep Quality Index) - You own a smartphone (iPhone with iOS 14+ or Android 6+) with internet or data access - You are 18 or older and can read and understand English - You are willing to be randomly assigned to a study group and attend blood draw appointments **You may NOT be eligible if...** - You are currently in a drug treatment clinical trial - You are planning to receive an allogeneic stem cell transplant (using a donor's stem cells) within 20 weeks - You do not own a compatible smartphone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALWellness app intervention #1

This is the active intervention group.

BEHAVIORALWellness app intervention #2

This is the active comparator/control group.


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

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NCT05294991


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