Trial Outcomes & Findings for Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors (NCT NCT06053268)

Recruitment occurred 5/23/24-2/4/25. Potential participants were identified by St. Jude Life and provided to the psychology study team. The participants' medical records were reviewed in Epic to assess eligibility. Eligible participants were contacted via email, followed by a phone call. Upon contact, participants were screened for remaining criteria following an Institutional Review Board (IRB) approved script.

After completing consent, participants had a 7-day wash-out period in which they wore the Empatica Embrace Plus smartwatch to establish a baseline. Intervention started after the 7-day wash-out was complete.

Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors

Mindfulness app adherence was defined as the proportion of participants who completed at least 4 meditation sessions on average during the 30-day intervention.

Treatment Acceptability and Adherence Scale - Participants will rate on a 0 ("Strongly disagree") to 7 ("Strongly agree") scale regarding their perceptions of acceptability of the mindfulness intervention (10 items). Scores range from 0-70. An overall score is provided with higher scores indicating higher intervention acceptability.

An adapted version of the Treatment Acceptability and Adherence Scale was created to evaluate ecological momentary assessment acceptability (7 items). Scores range from 0-49. An overall score is provided with higher scores indicating higher intervention acceptability.

Biosensor adherence was defined as the proportion of participants who wore the wrist-worn biosensor for at least 10 hours per day across the approximately 37-day study window.

This measure is a 10-item, widely used and validated assessment of stress and efficacy of managing stress. The Participants are asked to respond to each question on a 5-point Likert scale ranging from 0 (never) to 4 (very often), indicating how often they have felt or thought a certain way within the past month. A single score is provided and ranges from 0 to 40. Higher scores indicate higher levels of stress.

The Brief COPE is a validated measure of coping strategies. Six subscales were included in this analysis: behavioral disengagement, planning, positive reframing, meditation/religious coping, self-blame, and emotional support. Participants rated each item on a 4-point Likert scale, and subscale scores range from 2 to 8 for each domain, with higher scores indicating greater use of the given coping strategy. Higher scores are not uniformly better or worse outcomes because interpretation depends on the coping strategy; for example, higher planning, positive reframing, and emotional support generally reflect greater use of adaptive coping strategies, whereas higher behavioral disengagement and self-blame reflect greater use of maladaptive coping strategies.

Oxidized low-density lipoprotein was measured from dried blood spot specimens as a biomarker of oxidative modification of low-density lipoprotein particles. Values are reported in units per liter. Higher values indicate greater oxidized low-density lipoprotein concentrations.

Pro-B-type natriuretic peptide was measured from dried blood spot specimens as a biomarker related to cardiac wall stress. Values are reported as log-transformed concentrations in picograms per milliliter (log pg/mL). Higher values indicate higher pro-B-type natriuretic peptide concentrations.

P-selectin was measured from dried blood spot specimens as a biomarker of platelet activation and vascular inflammation. Values are reported as log-transformed concentrations in picograms per milliliter (log pg/mL). Higher values indicate higher P-selectin concentrations.

Vascular cell adhesion molecule-1 was measured from dried blood spot specimens as a biomarker of endothelial activation and vascular inflammation. Values are reported in nanograms per milliliter. Higher values indicate higher vascular cell adhesion molecule-1 concentrations.

Homocysteine was measured from dried blood spot specimens as a biomarker related to vascular and cardiometabolic risk. Values are reported in micromoles per liter. Higher values indicate higher homocysteine concentrations.

High-sensitivity C-reactive protein was measured from dried blood spot specimens as a biomarker of systemic inflammation. Values are reported in milligrams per liter. Higher values indicate higher systemic inflammation.