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Mindfulness App for Childhood Cancer

N/A

Waitlist Available

Led By Rachel Webster, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Research participant is at least 18 years old at enrollment

Research participant has a diagnosis history of leukemia or lymphoma

Must not have

Research participant takes psychiatric medications or medications that impact cardiac functioning, beta-blockers, alpha-blockers

Research participant has a diagnosis of a congenital heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days (during intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how a mobile mindfulness app and digital health data collection can help survivors of childhood cancer cope with stress.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves mindfulness through an app, there aren't typical medical side effects. However, participants might experience emotional discomfort when confronting stressful thoughts during meditation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My pain significantly interferes with my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days (during intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days (during intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days (during intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Data collection feasibility.

EMA data collection acceptability

Intervention acceptability

+1 more

Secondary study objectives

Brief Cope inventory is a 28-item, validated assessment measure of positive and negative coping strategies across 14 domains. Participants respond on a 4 point Likert scale how often they have engaged in a particular coping strategy

Perceived Stress Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-arm, within-subject pilot: EmbracePlus smartwatchExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Headspace

2020

N/A

~220

0 / 5Eligibility criteria met