Recruiting

MBSR

Sponsor:

Kimberley Roche

Code:

NCT07420101

Conditions

Caregiver Anxiety

Caregiver Anxiety Related to Cancer Imaging

Pediatric Oncology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mindful Module Caregiver Packet

Study Details

Brief summary:

"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.

Conditions

Caregiver Anxiety

Caregiver Anxiety Related to Cancer Imaging

Pediatric Oncology

Study ID

NCT07420101

Start date

Feb 1, 2026

Status verified date

Feb, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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).

Primary outcome measure

  • Likert-Style Anxiety Scale [ Time Frame: 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. ]
  • Feasibility of the Program [ Time Frame: 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. ]
  • Intervention Appropriateness Measure (IAM) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Kimberley Roche, MSN, PPCNP-BC, APRN

860-545-9671KRoche01@connecticutchildrens.org

Adam Barselau, MS

860-545-9671Abarselau@connecticutchildrens.org

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Kimberley Roche, APRN

(860) 545-8343KRoche01@connecticutchildrens.org

Adam Barselau, M.S.

8605459630Abarselau@connecticutchildrens.org

More Information

Sponsor

Kimberley Roche

Last update posted

Mar 19, 2026

Last verified

Feb, 2026

Keywords

  • Scanxiety
  • caregiver anxiety
  • caregiver support
  • meditation
  • mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kimberley Roche on 2026-03-19.