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Meditation for Sleep Disturbance in Cancer Patients (REST-C Trial)
N/A
Waitlist Available
Led By Jennifer Huberty, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has not received/planning to receive an allogenic stem cell transplantation)
≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
REST-C Trial Summary
This trial is testing whether an app-based meditation intervention can reduce sleep disturbance, fatigue, emotional distress, and inflammatory markers in people with HIV who are also on stable CHC pharmacologic therapy.
Who is the study for?
This trial is for adults over 18 with chronic hematological cancer on stable treatment, experiencing sleep disturbances but not diagnosed with a sleep disorder or using sleep medication more than three times weekly. Participants must own a smartphone, be willing to use an app and attend lab visits for blood draws.Check my eligibility
What is being tested?
The study tests if daily meditation via the Calm app can improve sleep quality compared to listening to health education podcasts. It measures effects on sleep disturbance, fatigue, emotional distress, and inflammatory markers over an 8-week intervention and a 12-week follow-up.See study design
What are the potential side effects?
Since this trial involves non-pharmacological interventions like meditation and educational podcasts, significant side effects are not anticipated. However, participants may experience changes in mood or increased awareness of personal health issues.
REST-C Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had, nor plan to have, a stem cell transplant from a donor.
Select...
I am 18 years old or older.
Select...
I have not had, nor plan to have, a stem cell transplant from a donor.
Select...
I haven't changed my sleep medication, including over-the-counter ones, in the last six weeks.
Select...
My blood cancer is stable under current treatment or observation.
Select...
I have not had, nor plan to have, a stem cell transplant from a donor.
Select...
I am 18 years old or older.
REST-C Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleep Disturbance (subjective)
Sleep disturbance (objective)
Sleep disturbance (subjective)
Secondary outcome measures
Anxiety (subjective)
Depression (subjective)
Fatigue (subjective)
+1 moreOther outcome measures
Meditation Participation
Podcast Participation
REST-C Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Calm MeditationExperimental Treatment1 Intervention
Participants assigned to the Calm group will be asked to complete a minimum of 10 minutes per day of meditation, at any time of day they choose for eight weeks. During weeks 1-4 participants in the Calm group will be asked to complete the introductory 30-day program "How to Meditate". Weeks 5-8, participants will be asked to complete one daily meditation that may include the "Daily Calm," a different 10-minute mindfulness meditation each day, or a meditation from a various series of meditations (e.g., loving-kindness, seven days of managing stress). Participants will have complete autonomy to choose the meditation. After the participant has completed their daily meditation, participants will also be able to use the app content more broadly based on their preference.
Group II: Health Education PodcastActive Control1 Intervention
Similar to the Calm group, participants in the POD group will listen to a minimum of 10 minutes per day of a health education podcast delivered via a mobile app for eight weeks. Content was carefully chosen to exclude any recommendations for sleep, meditation, or for mindfulness-like principles or practice. A library of podcasts is available on the app. Participants are able to select the podcast based on title, time or both in an effort to mirror the delivery of the meditations in the Calm group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calm Meditation
2020
N/A
~110
Find a Location
Who is running the clinical trial?
University of TexasOTHER
187 Previous Clinical Trials
142,177 Total Patients Enrolled
Arizona State UniversityOTHER
283 Previous Clinical Trials
109,238 Total Patients Enrolled
Wake Forest University Health SciencesOTHER
1,239 Previous Clinical Trials
1,003,907 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am planning to start a new drug treatment for my cancer.I take less than 3 sleep aids and can keep or stop their use as advised for the study.You are not currently involved in another drug treatment study.My blood cancer is stable under current treatment or observation.I have not had, nor plan to have, a stem cell transplant from a donor.I can go to a nearby lab for blood tests 3 times over 20 weeks.I am 18 years old or older.You have been practicing meditation or meditative movements for at least 60 minutes per week in the last 2 months.I have been diagnosed with a sleep disorder that is not insomnia.I have not had, nor plan to have, a stem cell transplant from a donor.I am willing to download and use a mobile app.I have no uncontrolled medical or mental health conditions.You have a sleep quality score higher than 5 on the PSQI.You are okay with being randomly placed into a treatment group.I am 18 years old or older.I am willing to download and use a mobile app.I am taking 3 or more sleep aids, prescribed or over-the-counter.You have a sleep quality score higher than 5 on the Pittsburgh Sleep Quality Index (PSQI).You are willing to use a phone app.My blood cancer is stable and I haven't changed my medication or its dose in the last 2 months.You have a sleep quality score higher than 5 on the Pittsburgh Sleep Quality Index.You have a smartphone that runs iOS 9.0 or later if you have an iPhone or Android 4.1 or later if you have an Android phone.I have not had, nor plan to have, a stem cell transplant from a donor.You are okay with being chosen randomly for the study.I haven't changed my sleep medication, including over-the-counter ones, in the last six weeks.I can drive to Quest Diagnostics 3 times in the morning during the study.You are not currently enrolled in a drug treatment study.You have a mobile phone that runs on iOS 14.0 or later (if you have an iPhone) or Android 6.0 or later.
Research Study Groups:
This trial has the following groups:- Group 1: Calm Meditation
- Group 2: Health Education Podcast
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sleep Disorder Patient Testimony for trial: Trial Name: NCT05294991 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What key outcomes is this trial striving to achieve?
"According to the trial sponsor, Laboratory Corporation of America, the main objective is assessing changes in sleep disturbance over a time period. This will be measured at baseline, week 8 and week 20 using an eight item Likert scale which converts into a standardized t-score. Secondary objectives include evaluating fatigue with PROMIS Adult Cancer Fatigue Short Form 7a (7 items on 1-5 Likert scale), anxiety with PROMIS Emotional Distress-Anxiety Short Form 7a (also seven items) and depression with PROMIS Emotional Distress-Depression Short Form 8a (eight items)."
Answered by AI
Are individuals able to enroll for this clinical experiment at present?
"Unfortunately, the clinical trial listed on clinicaltrials.gov is no longer enrolling participants; however, this information was last updated November 9th 2022. There are currently 2430 other trials actively recruiting patients in its stead."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Other
Texas
California
How old are they?
18 - 65
What site did they apply to?
Mays Cancer Center at UT Health San Antonio
Calm, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
Why did patients apply to this trial?
Sick of poor sleep. I suffer from social anxiety and would like to change.
PatientReceived no prior treatments
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