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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053268
• Other study ID #: MINDHACS
• Secondary ID: NCI-2023-09351
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: May 2024
• Source: St. Jude Children's Research Hospital
• Contact: Rachel Webster, PhD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Childhood Cancer
• Leukemia
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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]
Primary	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
Primary	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	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
Secondary	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

External Links

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