Wellness App for Sleep Disturbance in Hematological Cancer Patients

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.

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.

Sponsors & Collaborators

• Arizona State University

  collaborator OTHER

• Laboratory Corporation of America

  collaborator INDUSTRY

• Wake Forest University Health Sciences

  collaborator OTHER

• Calm.com, Inc.

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• Jennifer Huberty, PhD · UT Health San Antonio

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-20

Primary Completion

2026-10-31

Completion

2026-10-31

Countries

• United States

Study Locations