LeukemiaNCT06053268
Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
A study testing Headspace in people with Leukemia and Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphoma, Childhood Cancer
- What is being tested?
- Headspace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2024to 27 Sep 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Leukemia, Lymphoma, Childhood Cancer
- Being tested
- Headspace
- Medical subject headings
- Leukemia, Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeadspaceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, Within-subject Feasibility Pilot: | Experimental | 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. Receives: Device: Headspace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 37 days over the study window (7-day baseline washout plus 30-day intervention)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 1 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start23 May 2024
- Primary completion9 May 2025
- Study completion27 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Webster, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053268
- Sponsor's protocol ID
- MINDHACS
- Other IDs
- NCI-2023-09351
- Status last verified
- Jun 2026
- First submitted
- 7 Sep 2023
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT06053268
- Acronym / sponsor ID
- MINDHACS
- Conditions
- Leukemia, Lymphoma, Childhood Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 27 Sep 2026 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Posted 23 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm, Within-subject Feasibility Pilot: | Experimental | Device: HeadspaceSingle-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeadspaceThe 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 | Device | Single-arm, Within-subject Feasibility Pilot: |
Primary outcome
Mindfulness App Adherence
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
8 secondary outcomes
Perceived Stress Scale
Time frame: Baseline and up to 1 week post intervention
Brief Coping Orientation to Problems Experienced (COPE)
Time frame: Baseline and up to 1 week post intervention
Oxidized Low-Density Lipoprotein
Time frame: Baseline and up to 1 week post intervention
Pro-B-type Natriuretic Peptide
Time frame: Baseline and up to 1 week post intervention
P-selectin
Time frame: Baseline and up to 1 week post intervention
Vascular Cell Adhesion Molecule-1
Time frame: Baseline and up to 1 week post intervention
Homocysteine
Time frame: Baseline and up to 1 week post intervention
High-sensitivity C-Reactive Protein
Time frame: Baseline and up to 1 week post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Webster, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headspace in people with Leukemia and Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness App Adherence (time frame: 30 days (during intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.