This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
The goal of this clinical trial is to evaluate the SMILE app, a Digital Health Platform (DHP), that will deliver a mindfulness intervention, designed to mitigate COVID-19 related stress. Additionally, the SMILE app will remotely collect self-reported psychological and physiological metrics of mental health and autonomic regulation. Study participants are adults who self-identify as African American, Black and/or Latino, and who have clinically significant levels of anxiety. The study aims are: * Aim 1: Establish the effectiveness and durability of an 8-week Mindfulness DHP intervention. The investigators will focus on two constructs important to mental health and hypothesize that: A) Anxiety, self-report stress and quality-of-life measures will significantly improve when comparing: A.1) Pre-to-post intervention, and; A.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. B) Arousal, autonomic indices of HRV (reflecting parasympathetic activation) will significantly improve, when comparing: B.1) Pre-to-post intervention, and; B.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. * Aim 2: Establish the sustainability of two Mindfulness DHP interventions utilizing retention, usage (frequency), and participant satisfaction. * Aim 3: Examine associations between COVID-19 related stress, mental health outcomes, and HRV. Examine the extent to which COVID-19 related stress and mental health symptoms are linked to HRV at baseline and how that relationship changes over time. Participants will be assigned to 1 of 3 arms of the study: MTIA intervention, MAPP intervention, or wait-list control. All participants will be mailed a device with the SMILE app installed, and the equipment for recording cardiac data in the home. All participants will complete the baseline psychometrics measures and physiological stress test using the instructions provided on the SMILE app. Those assigned to the MTIA or MAPP intervention groups will then participate in their assigned intervention over the subsequent 8 weeks. During these 8 weeks, psychometric and physiological data will be completed biweekly for all participants. 3 months following the initial baseline, all participants will complete a final psychometric/physiological evaluation.
Digital Health Platform (DHP) to Deliver Mindfulness as a Stress Management Intervention Leveraging Electronic (SMILE) Health Records for Racial and Ethnic Populations During the COVID-19 Pandemic: Clinical Trial
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Sponsor: University of North Carolina, Chapel Hill
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.