Childhood Cancer, Leukemia, Lymphoma
Conditions
Brief summary
This study will explore feasibility and acceptability of using a daily mobile mindfulness app to cope with stress. In addition, feasibility of digital health data collection procedures including wrist-worn devices and ecological momentary assessments will be examined. PRIMARY OBJECTIVES * Determine the feasibility and acceptability of completing the 30-day mobile mindfulness program * 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 SJLIFE cohort * 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 ANS activation, coping, health behaviors, and cardiometabolic outcomes in a cohort of survivors of childhood cancer.
Detailed description
Prior to engaging in the intervention participants will complete baseline assessments of stress and coping. Participants will then engage in a daily mindfulness practice via the Headspace mobile application. The basic application program includes daily 10-minute sessions in guided mindfulness meditation that include mindful breathing, body awareness, emotion and thought recognition, and attentional control. During the first and fourth week of the intervention, participants will complete EMAs assessing mood, current activity, and intervention engagement. Participants will also wear a wrist-worn device to assess biomarkers of stress. At the completion of the intervention participants will complete follow-up assessments related to intervention and data collection procedures feasibility and acceptability as well as coping behaviors and stress.
Interventions
DEVICEHeadspace
The intervention was delivered via the Headspace mobile application. The basic application program includes daily 10-minute sessions in guided mindfulness meditation that include mindful breathing, body awareness, emotion and thought recognition, and attentional control
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Research participant is at least 18 years old at enrollment * Research participant is followed by St. Jude Children's Research Hospital (SJCRH) * Research participant has a diagnosis history of leukemia or lymphoma * Research participant takes part in the St. Jude Lifetime Cohort Study (SJLIFE) * Research participant has elevated psychological stress scores of 6 or greater on most recent SJLIFE questionnaire * Participant can speak and read English
Exclusion criteria
* Research participant currently engages in mindful stress-reduction practices \>2x per week (e.g., tai chi, meditation) * Research participant takes psychiatric medications or medications that impact cardiac functioning, beta-blockers, alpha-blockers * Research participant wears a pacemaker * Research participant has a diagnosis of a congenital heart disease * Research participant has no access to a smartphone * Research participant has elevated pain interference scores (T≥70)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness App Adherence | 30 days (during intervention) | Mindfulness app adherence was defined as the proportion of participants who completed at least 4 meditation sessions on average during the 30-day intervention. |
| Intervention Acceptability | Up to 1 week post 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. |
| Ecological Momentary Assessment Data Collection Acceptability | Up to 1 week post intervention | 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 (Wrist-worn Device) Adherence | Approximately 37 days over the study window (7-day baseline washout plus 30-day intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale | Baseline and up to 1 week post intervention | 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. |
| Brief Coping Orientation to Problems Experienced (COPE) | Baseline and up to 1 week post intervention | 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 | Baseline and up to 1 week post intervention | 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 | Baseline and up to 1 week post intervention | 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 | Baseline and up to 1 week post intervention | 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 | Baseline and up to 1 week post intervention | 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 | Baseline and up to 1 week post intervention | 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 | Baseline and up to 1 week post intervention | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRachel Webster, PhD
St. Jude Children's Research Hospital
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 28.36 Years STANDARD_DEVIATION 5.45 |
| Race/Ethnicity, Customized Hispanic | 7 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 13 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 27 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Region of Enrollment United States | 50 Participants |
| Sex/Gender, Customized Female | 32 Participants |
| Sex/Gender, Customized Male | 17 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
None listed