Wellness App for Sleep Disturbance in Hematological Cancer Patients
Heme
Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients
2 other identifiers
interventional
276
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Feb 2023
Typical duration for not_applicable cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 24, 2022
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
February 19, 2026
February 1, 2026
3.7 years
March 15, 2022
February 17, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Sleep Disturbance (subjective)
Sleep disturbance will be measured with the Insomnia Severity Index (ISI). Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.
Changes in sleep disturbance will be measured at baseline, week 2, week 4, week 6, week 8, and week 20. Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.
Sleep Disturbance (subjective)
Sleep disturbance will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8b. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Changes in sleep disturbance will be measured at baseline, week 8, and week 20. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep Disturbance (subjective)
Sleep disturbance will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Changes in sleep disturbance will be measured at baseline, week 8, and week 20. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep disturbance (subjective)
Sleep disturbance will be measured with an investigator-developed weekly sleep diary
Changes in sleep disturbance will be measured weekly throughout the 8-week intervention period and once again during the week 20 follow-up period.
Sleep disturbance (objective)
Sleep disturbance will be measured with wrist actigraphy
Changes in sleep disturbance will be measured weekly throughout the 8-week intervention period and once again during the week 20 follow-up period.
Secondary Outcomes (4)
Inflammation
Changes in inflammation will be measured at baseline, week 8, and week 20.
Fatigue (subjective)
Changes in fatigue will be measured at baseline, week 8, and week 20.
Anxiety (subjective)
Changes in anxiety will be measured at baseline, week 8, and week 20.
Depression (subjective)
Changes in fatigue will be measured at baseline, week 8, and week 20.
Other Outcomes (1)
Wellness app engagement
Changes in engagement will be measured by minutes used per day/week on a weekly basis throughout the 8-week intervention period.
Study Arms (2)
Wellness app intervention #1
EXPERIMENTALParticipants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app.
Wellness app intervention #2
ACTIVE COMPARATORParticipants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app.
Interventions
This is the active intervention group.
This is the active comparator/control group.
Eligibility Criteria
You may qualify if:
- 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)
- Not currently participating in a therapeutic pharmacologic clinical trial
- Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks)
- Score of \>5 on PSQI (Pittsburgh Sleep Quality Index)
- Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection
- Willing to download two mobile apps
- Able to read/understand English
- ≥18 years of age
- Willing to be randomized
- 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)
- 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)
You may not qualify if:
- Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months
- Reside outside of the United States of America
- Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes)
- Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire)
- 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
- Any other diagnosed and uncontrolled medical or psychiatric condition
- Has a pacemaker
- Shift work schedule
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arizona State Universitycollaborator
- Laboratory Corporation of Americacollaborator
- Wake Forest University Health Sciencescollaborator
- Calm.com, Inc.collaborator
- National Cancer Institute (NCI)collaborator
- The University of Texas Health Science Center at San Antoniolead
Study Sites (3)
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
Related Publications (1)
Huberty J, Bhuiyan N, Eckert R, Larkey L, Petrov M, Todd M, Mesa R. Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance. JMIR Res Protoc. 2022 Jul 1;11(7):e39007. doi: 10.2196/39007.
PMID: 35776489DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Huberty, PhD
The University of Texas Health Science Center at San Antonio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
March 24, 2022
Study Start
February 20, 2023
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share