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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Headspace for childhood cancer?

Research shows that mindfulness-based treatments, like those delivered through apps, can help reduce stress and improve well-being in cancer patients. Mindfulness training has been effective in reducing psychological stress and improving outcomes in cancer survivors, suggesting potential benefits for children with cancer using the Headspace app. ^{1 2 3 4 5}

Is the mindfulness app safe for children with cancer?

Mindfulness-based interventions, including apps, have been generally well accepted and beneficial for children with cancer, with no major safety concerns reported in the studies reviewed. ^{1 2 6 7 8}

How does the mindfulness app treatment for childhood cancer differ from other treatments?

The mindfulness app for childhood cancer is unique because it offers a digital, self-help approach to improve psychosocial well-being, focusing on reducing stress and depressive symptoms through mindfulness practices. Unlike traditional treatments that may involve medication or face-to-face therapy, this app provides an accessible and interactive platform that can be used independently by young patients. ^{8 9 10 11 12}

Research Team

Rachel Webster, PhD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Ireland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. [2008]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Reach versus effectiveness: The design and protocol of randomized clinical trial testing a smartphone application versus in-person mindfulness-based smoking cessation intervention among young cancer survivors. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mediators of Mindfulness-Based Stress Reduction (MBSR): assessing the timing and sequence of change in cancer patients. [2014]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Canada pubmed.ncbi.nlm.nih.gov

Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Symptom Management in Children and Adolescents With Cancer: A Systematic Review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Psychosocial Outcomes of a Mindfulness-Based Interactive e-Book for Young People with Cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Mindfulness Practices for Children and Adolescents Receiving Cancer Therapies. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Peaceful play yoga: serenity and balance for children with cancer and their parents. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Massage therapy for children with cancer. [2022]