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

NCT06053268 | Active Not Recruiting FDA Device

• 2 other identifiers: MINDHACSNCI-2023-09351
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Lymphoma; Childhood Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Perceived Stress Scale

  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

  Baseline and up to 1 week post intervention

Study Arms (1)

Single-arm, within-subject pilot: EmbracePlus smartwatch

EXPERIMENTAL

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

Interventions

Headspace DEVICE

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

Single-arm, within-subject pilot: EmbracePlus smartwatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Leukemia; Lymphoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rachel Webster, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 25, 2023
• Study Start: May 23, 2024
• Primary Completion: May 9, 2025
• Study Completion (Estimated): September 27, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• 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.

Locations

US (1)