Easing Scan Anxiety in Pediatric Oncology Caregivers Through Meditation-based Programs

March 17, 2026 updated by: Kimberley Roche

A Mindfulness Approach to Scanxiety

"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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment. It is multifactorial and includes anxiety leading up to the scan as well as the waiting period after imaging and prior to results, as well as worry about possible changes in treatment. It has been documented in adult oncology literature and is associated with lower quality of life. Past adult studies show an inverse relationship with time since diagnosis and scanxiety, the further out from diagnosis, the lower level of scanxiety. Scanxiety is higher in those with lower education levels and higher baseline anxiety. Though scanxiety has been sparsely acknowledged in pediatric oncology literature, anxiety has been documented in parents of pediatric patients receiving MRI's for various diagnoses. Although caregivers of pediatric oncology patients experience high levels of distress, to date there are no studies that have measured the presence of scanxiety specifically in caregivers of pediatric oncology patients. Therefore, there are no intervention studies attempting to ameliorate anxiety related to imaging in the caregivers of pediatric oncology patients.

Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. Its effects of reducing stress and other stress-related outcomes including anxiety is documented in various populations including police officers, prison inmates, university students, adolescents with cardiac diagnoses, and healthcare professionals. It has also been used to decrease stress in oncology patients and the partners of adult oncology patients. MBSR sessions can be provided in person but are also effective in an online training format. Although it has been well-studied in a variety of populations, the effectiveness of MBSR has yet to be evaluated in the caregivers of pediatric oncology patients. In particular, this study aims to fill the scientific gap in exploring if MSBR may reduce scanxiety in this population.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Phase 1: Scanxiety Assessment

To 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 Group

Phase 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.
Other: Mindful Module Caregiver Packet
If 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likert-Style Anxiety Scale
Time Frame: Caregivers will complete this 2 weeks before the scan.
Used to determine if the caregivers of pediatric oncology patients experience scanxiety. This one-item instrument scale ranges from 1 (not anxious at all) to 5 (extremely anxious). The goal of this instrument is to grossly establish if Scanxiety is present in caregivers. If caregivers answer between 2 (A little anxious)-5 (Extremely anxious) it demonstrates levels of anxiety.
Caregivers will complete this 2 weeks before the scan.
State-Trait Anxiety Inventory (STAI)
Time Frame: If anxiety is demonstrated in caregivers, they will move into Phase 2 of this study either in the Intervention Arm or the Control Arm. The State-Trait Anxiety Inventory (STAI) will be administered on Timepoint Day 1 and again on Timepoint Day 7.
Used to determine if the caregivers of pediatric oncology patients experience scanxiety. This 40-item self-reported survey measures anxiety. These 40 questions are divided into two 20-quesiton sections (one for "state" anxiety, and one for "trait" anxiety). Higher scores demonstrate high levels of anxiety. the scores range from 20-80 [very high anxiety (> 65), high anxiety (56-65), moderate anxiety (46-55), low anxiety (36-45) and very low anxiety (< or = 35).
If anxiety is demonstrated in caregivers, they will move into Phase 2 of this study either in the Intervention Arm or the Control Arm. The State-Trait Anxiety Inventory (STAI) will be administered on Timepoint Day 1 and again on Timepoint Day 7.
Feasibility of the Program
Time Frame: Will be administered to caregivers in the Intervention Arm Only on Day 7.
This questionnaire measures the ease of completion of the mindfulness modules, the perceived appeal of the mindfulness program, participant interest, likelihood of recommending the program to others, and participation in other mindfulness-based activities (e.g., yoga or meditation) outside of the study in a YES or NO response format.
Will be administered to caregivers in the Intervention Arm Only on Day 7.
Acceptability of Intervention Measure (AIM)
Time Frame: Will be administered to both Intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in similar programs and its perceived applicability. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Will be administered to both Intervention and Control Arm on both Day 1 and Day 7.
Intervention Appropriateness Measure (IAM)
Time Frame: Timeframe: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in similar programs its, perceived applicability and the likelihood of recommendation to other oncology families. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Timeframe: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
Feasibility of Intervention Measure (FIM)
Time Frame: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in its ease of completion. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Will be administered on both intervention and Control Arm on both Day 1 and Day 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kimberley Roche

Collaborators

UConn Health
Connecticut Children's Medical Center

Investigators

  • Principal Investigator: Kimberley Roche, MSN, PPCNP-BC, APRN, Connecticut Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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