Reducing Sleep disTurbance in Cancer

Major Program
Supportive Care and Symptom Management
Sponsor
The University of Texas Health Science Center at San Antonio
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05294991
In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention: the active daily meditation intervention (Calm) or the health education podcast control group (POD), 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 daily meditation (10 minutes/day) delivered via Calm compared to POD 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.

Hypothesis: Participants who are administered Calm will experience reduced sleep disturbance, and improvements in secondary sleep outcomes compared to POD at eight weeks.

Aim 2: Test the efficacy of daily meditation (10 minutes/day) delivered via Calm compared to POD on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®).

Hypothesis: Participants who are administered Calm will have greater reductions in fatigue, emotional distress and inflammatory markers compared to POD at eight weeks.

Aim 3: Explore the sustained effects (i.e., 20 weeks from baseline) of Calm in CHC patients.

Hypothesis: (a) Participants in Calm will have greater reductions in sleep disturbance, fatigue, emotional distress and inflammatory markers compared to POD at 20 weeks; (b) Total meditation time and sustained meditation usage overtime, but not time of day or use of non-meditative content (e.g., Sleep Stories), will be related to improved outcomes at 20 weeks.
Intervention
Calm Meditation, Health Education Podcast
Condition
Cancer, Sleep Disturbance, Anxiety, Depression, Inflammation, Fatigue
Investigators
Jennifer Huberty, PhD, Supreet Kaur, MD, Jillian Johnson, PhD, Kimberlee Hunt

See list of participating sites