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

NCT06053268 | Active Not Recruiting Results 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)

• Mindfulness App Adherence

  Mindfulness app adherence was defined as the proportion of participants who completed at least 4 meditation sessions on average during the 30-day intervention.

  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). Scores range from 0-70. An overall score is provided with higher scores indicating higher intervention acceptability.

  Up to 1 week post intervention

• Ecological Momentary Assessment Data Collection Acceptability

  An adapted version of the Treatment Acceptability and Adherence Scale was created to evaluate ecological momentary assessment acceptability (7 items). Scores range from 0-49. An overall score is provided with higher scores indicating higher intervention acceptability.

  Up to 1 week post intervention

• Biosensor (Wrist-worn Device) Adherence

  Biosensor adherence was defined as the proportion of participants who wore the wrist-worn biosensor for at least 10 hours per day across the approximately 37-day study window.

  Approximately 37 days over the study window (7-day baseline washout plus 30-day intervention)

Secondary Outcomes (8)

• Perceived Stress Scale

  Baseline and up to 1 week post intervention

• Brief Coping Orientation to Problems Experienced (COPE)

  Baseline and up to 1 week post intervention

• Oxidized Low-Density Lipoprotein

  Baseline and up to 1 week post intervention

• Pro-B-type Natriuretic Peptide

  Baseline and up to 1 week post intervention

• P-selectin

  Baseline and up to 1 week post intervention

Study Arms (1)

Single-arm, Within-subject Feasibility Pilot:

EXPERIMENTAL

Single-arm, within-subject feasibility pilot: Participants completed a 30-day app-based mindfulness intervention with wearable biosensor monitoring, ecological momentary assessment, surveys, and blood specimen collection.

Device: Headspace

Interventions

Headspace DEVICE

The intervention was 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 Feasibility Pilot:

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

Limitations and Caveats

This single arm feasibility pilot was not powered to assess efficacy. Findings should be interpreted cautiously due to small sample size, lack of a comparison group, short follow up duration, and exploratory analyses.

Results Point of Contact

• Title: Rachel Webster, PhD
• Organization: St. Jude Children's Research Hospital

Rachel.Webster@STJUDE.ORG

901-595-7946

Study Officials

• Rachel Webster, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 23, 2026
• Results First Posted: July 23, 2026

Record last verified: 2026-06

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)