Mindfulness App for Childhood Cancer

Overseen By Rachel Webster, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Must not be taking: Psychiatric, Cardiac, Beta-blockers, Alpha-blockers

Disqualifiers: Mindful practices, Pacemaker, Congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a daily mindfulness app, such as Headspace, can help manage stress in individuals who survived childhood cancer. Participants will use the app for 30 days to practice mindfulness and wear a smartwatch to track stress signals in the body. The goal is to assess the practicality and usefulness of using the app and collecting this data. Individuals who survived childhood leukemia or lymphoma, are part of the St. Jude Lifetime Cohort Study, and experience high stress levels might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance stress management for childhood cancer survivors.

Will I have to stop taking my current medications?

If you are taking psychiatric medications or medications that affect heart function, you may not be eligible to participate in this trial.

What prior data suggests that this mindfulness app and wearable device are safe for use in this study?

Research has shown that mindfulness apps, such as Headspace, are safe and well-liked by users, including children with cancer. No major safety issues have been reported for these apps. Studies also find that using Headspace can help reduce stress and anxiety, making it a useful tool for managing stress. Because this study uses a mindfulness app, it does not involve any medication, which typically means fewer risks. Overall, current evidence considers using an app like Headspace safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for managing stress in children with cancer, which often involve therapy sessions or medication, the Headspace mindfulness app offers a unique digital approach. This app provides guided mindfulness meditation sessions that focus on mindful breathing, body awareness, emotion and thought recognition, and attentional control—all accessible from a smartphone. Researchers are particularly excited about this method because it is easily accessible, non-invasive, and can be seamlessly integrated into daily routines, offering a flexible option that might be more engaging for young patients. Additionally, by using the EmbracePlus smartwatch to monitor stress biomarkers, this approach brings an innovative mix of technology and mental health care to track and potentially improve coping mechanisms in real-time.

What evidence suggests that this mindfulness app is effective for coping with stress in childhood cancer survivors?

Research has shown that mindfulness training can reduce stress and improve the well-being of cancer survivors. In this trial, participants will engage in daily mindfulness practice using the Headspace app. Studies have found that using the Headspace app for mindfulness meditation can increase feelings of compassion and decrease aggression. Approximately 57% of studies on Headspace report positive results in mindfulness practice. Early evidence also suggests that meditation apps can reduce psychological distress in cancer patients. While more research is needed, these findings suggest that the Headspace app may help childhood cancer survivors manage stress. ^{3 6 7 8 9}

Who Is on the Research Team?

Rachel Webster, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were treated at St. Jude Children's Research Hospital for leukemia or lymphoma, are part of the SJLIFE study, and experience high stress. They must speak English and have a smartphone but can't use mindfulness practices more than twice a week or take certain heart or psychiatric medications.

Inclusion Criteria

Research participant is followed by St. Jude Children's Research Hospital (SJCRH)

Participant can speak and read English

I have been diagnosed with leukemia or lymphoma in the past.

Exclusion Criteria

Research participant has no access to a smartphone

I take medication for mental health or heart issues, including beta-blockers or alpha-blockers.

I have been diagnosed with a heart condition present since birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete baseline assessments of stress and coping

1 week

Intervention

Participants engage in a daily mindfulness practice via the Headspace mobile application for 30 days

4 weeks

Daily self-guided sessions

Follow-up

Participants complete follow-up assessments related to intervention and data collection procedures feasibility and acceptability as well as coping behaviors and stress

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Headspace

Trial Overview

The trial tests if using the Headspace app daily helps childhood cancer survivors cope with stress better. It also checks how well wearable devices and moment-to-moment assessments work in measuring body responses to stress like skin temperature and pulse changes.

How Is the Trial Designed?

Group I: Single-arm, within-subject pilot: EmbracePlus smartwatch Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

Mindfulness-based stress reduction (MBSR) shows promising psychological benefits for cancer patients, as indicated by various instruments measuring its impact, although the effectiveness of these instruments varies.

The review highlights the need for more rigorous intervention studies on MBSR in cancer care to better understand its benefits and to refine the tools used to measure its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. Matchim, Y., Armer, JM.[2007]

Mindfulness-based interventions (MBIs) can help alleviate symptoms such as fatigue, anxiety, sadness, and anger in children with cancer, making them a valuable addition to treatment plans.

Various MBIs, including mindful movement and breath awareness, can be easily adapted for different ages and have been implemented with minimal training, suggesting they can be integrated into pediatric oncology care effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Practices for Children and Adolescents Receiving Cancer Therapies. Murphy, S., Donma, AJ., Kohut, SA., et al.[2023]

Mindfulness-based stress reduction training significantly improved quality of life and reduced physical symptoms in 47 cancer patients, with benefits observed immediately after training and even stronger effects reported one year later.

Participants experienced decreased mood disturbances, such as depression and anger, indicating that mindfulness training can help cancer patients manage stress and enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. Kieviet-Stijnen, A., Visser, A., Garssen, B., et al.[2008]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved sleep quality in 63 cancer patients, with overall sleep disturbance reduced (p < .001).

Participants also experienced significant reductions in stress, mood disturbance, and fatigue, suggesting that MBSR can enhance the overall quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Carlson, LE., Garland, SN.[2018]

An 8-week mindfulness treatment delivered through an app was feasible for some patients with brain tumors, with 20 participants starting the study, but only 10 completed it, highlighting challenges in recruitment and retention.

Participants who completed the program reported significant improvements in mindfulness and illness-related quality of life, although there was a decline in social/family quality of life, indicating the need for further research to optimize engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. De Tommasi, C., Richardson, E., Reale, M., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11121627/

Feasibility and Acceptability of a Meditation Mobile App ...

Mindfulness meditation has shown early efficacy in improving psychological distress among cancer patients. However, the overall scientific study of app-based ...

2.

withpower.com

withpower.com/trial/phase-leukemia-9-2023-8d3b0

Mindfulness App for Childhood Cancer · Info for Participants

Mindfulness training has been effective in reducing psychological stress and improving outcomes in cancer survivors, suggesting potential benefits for children ...

3.

headspace.com

headspace.com/science/meditation-research

Researching Meditation and Mindfulness

Separate studies conducted by Northeastern University found that 3 weeks of Headspace increased compassion by 23% and reduced aggression by 57%. In addition, an ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9533203/

Efficacy and Conflicts of Interest in Randomized Controlled ...

Trial Outcomes​​ Of the RCTs of Headspace that evaluated mindfulness, 57% (4/7) had positive findings, 14% (1/7) had mixed findings, and 29% (2/7) had null ...

5.

researchprotocols.org

researchprotocols.org/2020/5/e15178/

A Smartphone App–Based Mindfulness Intervention for ...

This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful ...

6.

headspace.com

headspace.com/enterprise-security

Personal Security and Privacy

Headspace is committed to protecting member privacy and ensuring the confidentiality, integrity, and availability of information.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10872959/

An updated meta-analysis of randomized controlled trials

Growing evidence indicates that mindfulness apps can acutely reduce symptoms of depression and anxiety, although higher quality studies with longer follow-ups ...

8.

mhealth.jmir.org

mhealth.jmir.org/2024/1/e52968

The Real-World Impact of App-Based Mindfulness on ...

Real-world use of Headspace is associated with decreased perceived stress. Furthermore, data suggest that more engagement, specifically weekly active days and ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7248798/

A Smartphone App–Based Mindfulness Intervention for ...

This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, ...