RECRUITING

Wellness App for Sleep Disturbance in Hematological Cancer Patients

Conditions

Cancer Sleep Disturbance Anxiety Depression Inflammation Fatigue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-02-20

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05294991

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Study Contact

Jillian Johnson, PhD

CONTACT

814-424-5601

jiajohns@wakehealth.edu

Principal Investigator

Jennifer Huberty, PhD

PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Study Locations (Sites)

Arizona State University

Phoenix, Arizona, 85004

United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27101

United States

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

San Antonio, Texas, 78229

United States

Collaborators and Investigators

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

Jennifer Huberty, PhD, PRINCIPAL_INVESTIGATOR, UT Health San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-20

Study Completion Date2026-07

Study Record Updates

Study Start Date2023-02-20

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

Cancer
Sleep Disturbance
Anxiety
Depression
Inflammation
Fatigue