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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma; Leukemia; Childhood Cancer
• Intervention / Treatment: Device: Headspace

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single-arm, within-subject pilot: EmbracePlus smartwatch; 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.

Device: Headspace; The intervention will be 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention feasibility.	Headspace provides user metrics including date/time of meditation sessions, number of sessions completed, average duration of each session, and total meditation minutes overall.	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).	up to 1 week post intervention]
Data collection feasibility.	Wearable Technology. EmbracePlus includes on-wrist detection, and this data will be used to evaluate how long and for how many days participants wear the device. EMA. Completion of EMA data will be calculated based on the number of assessments completed	up to 1 week post intervention
EMA data collection acceptability	An adapted version of the TAAS was created to evaluate EMA assessment acceptability (7 items). Higher scores are indicative of greater acceptability	up to 1 week post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Scores range from 0 to 40.	Baseline and up to 1 week post intervention
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	Digital biomarkers of ANS activation. EmbracePlus (Empatica, Milano, Italy) is a smartwatch engineered to collect physiological biomarkers associated with ANS activation including electrodermal activity (EDA), pulse rate variability, inter-beat interval, respiratory rate, skin temperature, blood volume pulse- each used to develop a stress experience composite score	Baseline and up to 1 week post intervention

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Rachel Webster, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Actual): May 9, 2025
• Study Completion (Estimated): September 27, 2026

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemic and Lymphatic Diseases; Neoplasms; Leukemia; Lymphoma
• Other Study ID Numbers: MINDHACS; NCI-2023-09351 (Other Identifier: NCI Clinical Trial Registration Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be made available at the time of article publication.
• IPD Sharing Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes