Easing Scan Anxiety in Pediatric Oncology Caregivers Through Meditation-based Programs
Part of paid clinical trials in Hartford, Connecticut.
- Sponsor
- Kimberley Roche
- Study ID
- NCT07420101
- Status
- Recruiting
Conditions
- Caregiver Anxiety
- Caregiver Anxiety Related to Cancer Imaging
- Pediatric Oncology
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Mindful Module Caregiver Packet — OTHERIf Scanxiety was identified, patient's caregiver will receive the Mindful Module Caregiver Packet. The intervention group will receive the daily module on Days 1-7; Day 7 being the day before scan. At the end of the module (Day 7), they will be directed to two surveys (STAI and Feasibility of the Program).
Study Details
"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment and has not been robustly studied in pediatric oncology caregivers. Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. The main purposes of this study are two-fold: 1). to determine if scanxiety exists in the caregivers of pediatric oncology patients and 2.) if scanxiety is found, does the implementation of a mindfulness program help to improve caregiver anxiety related to imaging.
Key Dates
- Start date
- Feb 1, 2026
- Status verified
- Feb 2026
- Primary completion
- Feb 1, 2027
- Completion
- Feb 1, 2027
Study Design
- Enrollment
- 160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: Phase 1: Scanxiety AssessmentTo see if patient caregiver reports scanxiety (2-5 on the Anxiety Likert Scale). Scanxiety Assessment to determine if patients are eligible to enroll in the study. Phase 1 : Two Weeks Prior to Scan, Enrolled Patients will complete * Demographics Form * Questions About Treatment Form * Likert-style anxiety scale These instruments will determine if patients have "Scanxiety" and can participate in Phase 2 of the study.
- Experimental: Phase 2: Intervention GroupPhase 2 participants will be randomized to either the intervention group or the control group using a random number generator sequence. Two weeks before the scan, those assigned to the Intervention Group will be mailed a Mindful Module Caregiver Packet (Days 2-7) to complete a week before their upcoming scan. On day one they will be sent the STAI Survey via REDCAp to complete along with Mindful Module 1. Each day there will a new module sent to their email. Days 2-7 participants will be sent a daily module. At the end of the module Day 7, the day before the scan, they will be directed to 2 surveys (STAI, Feasibility and Acceptability of the Program to complete before their scan). Control Group: Patient caregivers will not receive the Mindful Modules Caregiver Packet and will not get the sent the daily mindfulness modules. Will complete above surveys at above timelines as stated in Intervention Group.
Primary Outcome Measure
Likert-Style Anxiety Scale [ Time Frame: Caregivers will complete this 2 weeks before the scan. ]
Central Contacts
- Kimberley Roche, MSN, PPCNP-BC, APRN860-545-9671
- Adam Barselau, MS860-545-9671
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 |
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