An interventional study of Headspace in Leukemia, Lymphoma and Childhood Cancer, sponsored by St. Jude Children's Research Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Other
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
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.
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Exclusion Criteria:
Single-arm, within-subject feasibility pilot: Participants completed a 30-day app-based mindfulness intervention with wearable biosensor monitoring, ecological momentary assessment, surveys, and blood specimen collection.
Device: Headspace
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
Mindfulness App Adherence
Mindfulness app adherence was defined as the proportion of participants who completed at least 4 meditation sessions on average during the 30-day intervention.
Time frame: 30 days (during intervention)
Intervention Acceptability
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.
Time frame: Up to 1 week post intervention
Ecological Momentary Assessment Data Collection 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.
Time frame: Up to 1 week post intervention
Biosensor (Wrist-worn Device) Adherence
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.
Time frame: Approximately 37 days over the study window (7-day baseline washout plus 30-day intervention)
Perceived Stress Scale
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.
Time frame: Baseline and up to 1 week post intervention
Brief Coping Orientation to Problems Experienced (COPE)
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.
Time frame: Baseline and up to 1 week post intervention
Oxidized Low-Density Lipoprotein
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.
Time frame: Baseline and up to 1 week post intervention
Pro-B-type Natriuretic Peptide
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.
Time frame: Baseline and up to 1 week post intervention
P-selectin
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.
Time frame: Baseline and up to 1 week post intervention
Vascular Cell Adhesion Molecule-1
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.
Time frame: Baseline and up to 1 week post intervention
Homocysteine
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.
Time frame: Baseline and up to 1 week post intervention
High-sensitivity C-Reactive Protein
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.
Time frame: Baseline and up to 1 week post intervention
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.
| Milestone | Single-arm, Within-subject Pilot: EmbracePlus Smartwatch |
|---|---|
| Started | 50 |
| Completed | 45 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 4 |
| Milestone | Single-arm, Within-subject Pilot: EmbracePlus Smartwatch |
|---|---|
| Started | 45 |
| Completed | 45 |
| Not completed | 0 |
| Milestone | Single-arm, Within-subject Pilot: EmbracePlus Smartwatch |
|---|---|
| Started | 45 |
| Completed | 41 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 3 |
Mindfulness app adherence was defined as the proportion of participants who completed at least 4 meditation sessions on average during the 30-day intervention.
| Participants | Single-arm, Within-subject Pilot |
|---|---|
| Mindfulness App Adherence | 37 |
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.
| Total score | Single-arm, Within-subject Pilot |
|---|---|
| Intervention Acceptability | 51.95 ± 8.52 |
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.
| Total score | Single-arm, Within-subject Pilot |
|---|---|
| Ecological Momentary Assessment Data Collection Acceptability | 28.49 ± 4.69 |
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.
| Participants | Single-arm, Within-subject Pilot |
|---|---|
| Biosensor (Wrist-worn Device) Adherence | 36 |
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.
| Score | Single-arm, Within-subject Pilot |
|---|---|
| Baseline | 23.17 ± 3.83 |
| 1 Week Post Intervention | 23.32 ± 2.94 |
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.
| Score | Single-arm, Within-subject Pilot |
|---|---|
| Baseline: Behavioral Disengagement | 3.15 ± 1.31 |
| Baseline: Planning | 5.80 ± 1.60 |
| Baseline: Positive Reframing | 4.78 ± 1.90 |
| Baseline: Meditation/Religious Coping | 4.33 ± 2.13 |
| Baseline: Self-Blame | 5.29 ± 1.85 |
| Baseline: Emotional Support | 4.51 ± 1.70 |
| 1 Week Post Intervention: Behavioral Disengagement | 3.02 ± 1.39 |
| 1 Week Post Intervention: Planning | 6.24 ± 1.45 |
| 1 Week Post Intervention: Positive Reframing | 5.68 ± 1.57 |
| 1 Week Post Intervention: Meditation/Religious Coping | 5.30 ± 1.91 |
| 1 Week Post Intervention: Self-Blame | 4.93 ± 1.81 |
| 1 Week Post Intervention: Emotional Support | 4.93 ± 1.93 |
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.
| Units/liter | Single-arm, Within-subject Pilot |
|---|---|
| Baseline | 8.33 ± 5.95 |
| 1 Week Post Intervention | 8.26 ± 4.85 |
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.
| log pg/mL | Single-arm, Within-subject Pilot |
|---|---|
| Baseline | 4.12 ± 0.99 |
| 1 Week Post Intervention | 4.17 ± 1.10 |
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.
| log pg/mL | Single-arm, Within-subject Pilot |
|---|---|
| Baseline | 6.49 ± 0.49 |
| 1 Week Post Intervention | 6.62 ± 0.45 |
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.
| nanograms/milliliter | Single-arm, Within-subject Pilot |
|---|---|
| Baseline | 203.646 ± 58.32 |
| 1 Week Post Intervention | 183.79 ± 49.49 |
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.
| micromoles/liter | Single-arm, Within-subject Pilot |
|---|---|
| Baseline | 9.04 ± 2.34 |
| 1 Week Post Intervention | 8.37 ± 2.21 |
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.
| milligrams/liter | Single-arm, Within-subject Pilot |
|---|---|
| Baseline | 0.23 ± 0.33 |
| 1 Week Post Intervention | 0.13 ± 0.20 |
Collected over Baseline and up to 1 week post intervention. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-arm, Within-subject Pilot | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
Adult survivors of pediatric leukemia and lymphoma participated in a 30 day, app based mindfulness intervention delivered remotely, including daily guided meditation, ecological momentary assessments, wearable biosensor monitoring, and pre and post intervention assessments.
| Age, Continuous(Years) | Single-arm, Within-subject Pilot |
|---|---|
| Mean | 28.36 ± 5.45 |
| Sex/Gender, Customized(Participants) | Single-arm, Within-subject Pilot |
|---|---|
| Male | 17 |
| Female | 32 |
| Non-binary | 1 |
| Race/Ethnicity, Customized(Participants) | Single-arm, Within-subject Pilot |
|---|---|
| Hispanic | 7 |
| Non-Hispanic Black | 13 |
| Non-Hispanic White | 27 |
| Other | 3 |
| Region of Enrollment(Participants) | Single-arm, Within-subject Pilot |
|---|---|
| United States | 50 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Supporting information: Study protocol, Sap, Icf
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