Clinical trial NCT06053268: Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
Official title: Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Leukemia
Lymphoma
Childhood Cancer
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intervention feasibility.
timeFrame: 30 days (during intervention
measure: Intervention acceptability
timeFrame: up to 1 week post intervention]
measure: Data collection feasibility.
timeFrame: up to 1 week post intervention
measure: EMA data collection acceptability
timeFrame: up to 1 week post intervention
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline and up to 1 week post intervention
measure: 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
timeFrame: Baseline and up to 1 week post intervention
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Rachel Webster, PhD
role: PRINCIPAL_INVESTIGATOR
References: