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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

Must not have

Diagnosed with a sleep disorder except insomnia

Taking ≥3 prescribed sleep medications and/or over-the-counter drugs/supplements

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had, nor plan to have, a stem cell transplant from a donor.

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I am 18 years old or older.

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I have not had, nor plan to have, a stem cell transplant from a donor.

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I haven't changed my sleep medication, including over-the-counter ones, in the last six weeks.

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My blood cancer is stable under current treatment or observation.

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I have not had, nor plan to have, a stem cell transplant from a donor.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a sleep disorder that is not insomnia.

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I am taking 3 or more sleep aids, prescribed or over-the-counter.

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I have no uncontrolled medical or mental health conditions.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep Disturbance (subjective)

Sleep disturbance (objective)

Sleep disturbance (subjective)

Secondary study objectives

Anxiety (subjective)

Depression (subjective)

Fatigue (subjective)

+1 more

Other study objectives

Meditation Participation

Podcast Participation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met