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Mindfulness App for Childhood Cancer

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days (during intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Data collection feasibility.

EMA data collection acceptability

Intervention acceptability

+1 more

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,563 Total Patients Enrolled

77 Trials studying Leukemia

17,712 Patients Enrolled for Leukemia

Rachel Webster, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

2 Previous Clinical Trials

625 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients is the clinical trial accommodating?

"Correct. According to clinicaltrials.gov, this research study is currently accepting participants. It was initially posted on October 1st 2023 and subsequently updated on September 21st 2023. Fifty individuals are being recruited for the trial at one medical site."

Answered by AI

Is enrollment still open for this clinical trial?

"According to the data hosted on clinicaltrials.gov, this research project is presently accepting participants; it was originally launched on October 1st 2023 and its most recent update came out of September 21st 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors

2024. "Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06053268.

All > Leukemia