Wellness App for Sleep Disturbance in Hematological Cancer Patients

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05294991
Status
Recruiting
Apply to this trial

Conditions

  • Anxiety
  • Cancer
  • Depression
  • Fatigue
  • Inflammation
  • Sleep Disturbance

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wellness app intervention #1 — BEHAVIORAL
    This is the active intervention group.
  • Wellness app intervention #2 — BEHAVIORAL
    This is the active comparator/control group.

Study Details

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.

Key Dates

Start date
Feb 20, 2023
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
276 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Wellness app intervention #1
    Participants 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.
  • Active Comparator: Wellness app intervention #2
    Participants 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.

Primary Outcome Measure

Sleep Disturbance (subjective) [ Time Frame: 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. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Arizona State UniversityPhoenixArizona85004-
Wake Forest University School of MedicineWinston-SalemNorth Carolina27101
Jillian Johnson, PhD
[email protected]
814-424-5601
Ruben Mesa, MD (PRINCIPAL_INVESTIGATOR)
Mays Cancer Center at The University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Jillian Johnson, PhD
[email protected]
Jennifer Huberty, PhD (PRINCIPAL_INVESTIGATOR)
Supreet Kaur, MD (SUB_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Arizona State University· Phoenix, AZWake Forest University School of Medicine· Winston-Salem, NCMays Cancer Center at The University of Texas Health Science Center at San Antonio· San Antonio, TX

Related Studies