Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer… (NCT06053268) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
United States50 participantsStarted 2024-05-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mindfulness App Adherence
Timeframe: 30 days (during intervention)
2
Intervention Acceptability
Timeframe: Up to 1 week post intervention
3
Ecological Momentary Assessment Data Collection Acceptability
Timeframe: Up to 1 week post intervention
4
Biosensor (Wrist-worn Device) Adherence
Timeframe: Approximately 37 days over the study window (7-day baseline washout plus 30-day intervention)