Mindfulness to reduce scan-related anxiety in caregivers of children with cancer
A Mindfulness Approach to Scanxiety
This tests whether a mindfulness-based meditation program can help caregivers of children with cancer feel less anxious before, during, and after routine imaging scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT07420101 on ClinicalTrials.gov |
What this trial studies
This single-site interventional study first measures whether "scanxiety" occurs in caregivers of pediatric oncology patients using questionnaires timed around routine imaging visits. Eligible caregivers receive a Mindful Module Caregiver Packet and related digital communications to use before upcoming CT, MRI, or PET scans. Outcomes are caregiver-reported imaging-related anxiety and related quality-of-life measures collected by survey. The program is non-pharmacologic and delivered remotely via mailed materials and text-enabled devices, with exclusions for urgent, initial, or non-routine surveillance scans.
Who should consider this trial
Good fit: Adult (18+) English-speaking caregivers of pediatric oncology patients with a routine CT, MRI, or PET scan scheduled within the next three months who have access to a smartphone or tablet are the intended participants.
Not a fit: Caregivers of patients undergoing urgent scans for suspected relapse, initial diagnostic scans, non-routine surveillance, those who cannot read English, or those without a text-capable device are unlikely to be eligible or benefit from this intervention.
Why it matters
Potential benefit: If effective, the program could lower imaging-related anxiety for caregivers and improve their quality of life and coping during their child's cancer care.
How similar studies have performed: Mindfulness-based stress reduction has reduced stress and anxiety in various adult and non-oncology groups, but interventions targeting scan-related anxiety in pediatric oncology caregivers are novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to understand spoken English and be able to read written English * 18 years of age or older * Able to understand and willing to sign informed consent document * Have access to a smart phone or tablet device that is able to receive texts * Is a caregiver of any age oncology patient (including patients above 18 years of age) * Caregiver of a patient that is scheduled for a routine scan (CT's, MRI's, PET scans) within the upcoming 3 months * If assigned to the Phase 2 intervention group, willing and able to eat a raisin (a box of which will be mailed to home address) Exclusion Criteria: * Oncology patient is of adult age and caring for self * Medically-diagnosed cognitive delay in caregiver (by self-disclosure in eligibility questionnaire) * Upcoming scan is due to concern for relapse/disease recurrence and is urgent * Upcoming scan is part of initial oncology work-up * Any non-routine surveillance scan
Where this trial is running
Hartford, Connecticut
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Kimberley Roche, MSN, PPCNP-BC, APRN — Connecticut Children's Medical Center
- Study coordinator: Kimberley Roche, MSN, PPCNP-BC, APRN
- Email: KRoche01@connecticutchildrens.org
- Phone: 860-545-9671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.