This clinical trial evaluates whether a remote wearable device (like a smartwatch) and daily use of a mobile mindfulness meditation application (app) can help monitor and lower stress levels, improve ways patients deal with stress, and reduce patients risk of stress related diseases in childhood cancer survivors. Survivors of pediatric leukemia and lymphoma are at particular risk for severe-to-life threatening cardiometabolic dysfunction, that includes high blood pressure, dyslipidemia, obesity, and elevated blood glucose. Psychological stress is also associated with unhealthy coping strategies, such as substance use, physical inactivity, and poor diet, further worsening poor health outcomes. Given the negative impact of stress on health in a population vulnerable to cardiometabolic risk, it is important that survivors receive access to practical interventions that improve perceived stress and autonomic nervous system (ANS) activity associated with stress. Mindfulness meditation programs offer promise for addressing this gap in care and may help reduce stress among childhood cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06053268.
PRIMARY OBJECTIVES:
I. Determine the feasibility and acceptability of completing the 30-day mobile mindfulness program.
II. Evaluate the feasibility of digital health data collection procedures to detect autonomic nervous system (ANS) activation associated with stress (e.g., electrodermal activity, pulse rate variability, skin temperature) via wearable devices and self-reported ecological momentary assessments (EMA) among adult survivors of childhood cancer in the St. Jude Lifetime (SJLIFE) cohort.
III. Generate preliminary data to estimate the effect size and power needed for an extramurally funded randomized controlled trials (RCT) examining the impact of daily mindfulness mediation on biomarkers of autonomic nervous system (ANS) activation, inflammation (C-reactive protein [CRP], IL-6, TNF alpha, IL-1beta, NF-kappa B), cardiovascular function (p-selectin, vCAM-1, NT-proBNP, homocysteine), coping, health behaviors, and cardiometabolic outcomes in a cohort of survivors of childhood cancer.
OUTLINE:
Patients participate in mindfulness intervention via the Headspace mobile app over 10 minutes once daily (QD) for 30 days consisting of mindful breathing, body awareness, emotion and thought recognition, and attentional control. During week 1 and week 4, patients complete EMAs via text message three times a day (TID). Patients also wear the EmbracePlus smartwatch on study and may optionally undergo blood sample collection at baseline and follow-up.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorRachel Webster
