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

NCT07420101 | Recruiting

• 1 other identifier: 24-135
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 Related to Cancer Imaging; Caregiver Anxiety; Pediatric Oncology

Keywords

Scanxiety; caregiver anxiety; caregiver support; meditation; mindfulness

Outcome Measures

Primary Outcomes (6)

• Likert-Style Anxiety Scale

  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)

  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

  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)

  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)

  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)

  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.

Study Arms (2)

Phase 1: Scanxiety Assessment

NO INTERVENTION

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.

Phase 2: Intervention Group

EXPERIMENTAL

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

Interventions

Mindful Module Caregiver Packet OTHER

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).

Phase 2: Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand spoken English and be able to read written English
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kimberley Roche: lead
• Connecticut Children's Medical Center: collaborator
• UConn Health: collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Related Publications (17)

• Yu J, Han M, Miao F, Hua D. Using mindfulness-based stress reduction to relieve loneliness, anxiety, and depression in cancer patients: A systematic review and meta-analysis. Medicine (Baltimore). 2023 Sep 15;102(37):e34917. doi: 10.1097/MD.0000000000034917.

  PMID: 37713902 BACKGROUND

• Worthen M, Cash E. Stress Management. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK513300/

  PMID: 30020672 BACKGROUND

• Wexler TM, Schellinger J. Mindfulness-Based Stress Reduction for Nurses: An Integrative Review. J Holist Nurs. 2023 Mar;41(1):40-59. doi: 10.1177/08980101221079472. Epub 2022 Feb 25.

  PMID: 35213264 BACKGROUND

• Wang Y, Kou J, Han B. Effect of online modified mindfulness-based stress reduction training on the resilience of nursing interns in China. Nurs Open. 2023 Aug;10(8):5493-5499. doi: 10.1002/nop2.1788. Epub 2023 Apr 25.

  PMID: 37186462 BACKGROUND

• Voss A, Bogdanski M, Langohr B, Albrecht R, Sandbothe M. Mindfulness-Based Student Training Leads to a Reduction in Physiological Evaluated Stress. Front Psychol. 2020 May 14;11:645. doi: 10.3389/fpsyg.2020.00645. eCollection 2020.

  PMID: 32477199 BACKGROUND

• van den Hurk DG, Schellekens MP, Molema J, Speckens AE, van der Drift MA. Mindfulness-Based Stress Reduction for lung cancer patients and their partners: Results of a mixed methods pilot study. Palliat Med. 2015 Jul;29(7):652-60. doi: 10.1177/0269216315572720. Epub 2015 Feb 20.

  PMID: 25701663 BACKGROUND

• Vadvilavicius, T., Varnagiryte, E., Jarasiunaite-Fedorsejeva, G., & Gustainiene, L. (2023). The effectiveness of mindfulness-based stress reduction for police officers' stress reduction: a systematic review. Journal of Police and Criminal Psychology, 38(1), 223-239. https://doi.org.10.1007/s11896-022-09570-2

  BACKGROUND

• Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.

  BACKGROUND

• Scarponi D, Sarti P, Rivi V, Colliva C, Marconi E, Pession A, Blom JMC. Emotional, Behavioral, and Physical Health Consequences in Caregivers of Children with Cancer: A Network Analysis Differentiation in Mothers' and Fathers' Reactivity. Cancers (Basel). 2023 Jul 4;15(13):3496. doi: 10.3390/cancers15133496.

  PMID: 37444606 BACKGROUND

• Morel B, Andersson F, Samalbide M, Binninger G, Carpentier E, Sirinelli D, Cottier JP. Impact on child and parent anxiety level of a teddy bear-scale mock magnetic resonance scanner. Pediatr Radiol. 2020 Jan;50(1):116-120. doi: 10.1007/s00247-019-04514-1. Epub 2019 Sep 9.

  PMID: 31501961 BACKGROUND

• Lamothe M, Rondeau E, Duval M, McDuff P, Pastore YD, Sultan S. Changes in hair cortisol and self-reported stress measures following mindfulness-based stress reduction (MBSR): A proof-of-concept study in pediatric hematology-oncology professionals. Complement Ther Clin Pract. 2020 Nov;41:101249. doi: 10.1016/j.ctcp.2020.101249. Epub 2020 Oct 23.

  PMID: 33120117 BACKGROUND

• Kriakous SA, Elliott KA, Lamers C, Owen R. The Effectiveness of Mindfulness-Based Stress Reduction on the Psychological Functioning of Healthcare Professionals: a Systematic Review. Mindfulness (N Y). 2021;12(1):1-28. doi: 10.1007/s12671-020-01500-9. Epub 2020 Sep 24.

  PMID: 32989406 BACKGROUND

• Freedenburg, V. A., Hinds, P. S., & Friedmann, E. (2017). Mindfulness-based stress reduction and group support decrease stress in adolescent with cardiac diagnoses: A randomized two-group study. Pediatric Cardiology, 38(7), 1415-1425. https://doi.org.10.1007/s00246-017-1679-5

  BACKGROUND

• Derry-Vick, H. M., Heathcote, L. C., Glesby, N., Stribling, J., Leubke, M., Epstein, A. S., & Prigerson, H. G. (2023). Scanxiety among adults with cancer: A scoping review to guide research and interventions. Cancers (Basel), 15(5), 1381. https://doi.org.10.3390/cancers15051381

  BACKGROUND

• Bui KT, Liang R, Kiely BE, Brown C, Dhillon HM, Blinman P. Scanxiety: a scoping review about scan-associated anxiety. BMJ Open. 2021 May 26;11(5):e043215. doi: 10.1136/bmjopen-2020-043215.

  PMID: 34039571 BACKGROUND

• Bouw N, Huijbregts SCJ, Scholte E, Swaab H. Mindfulness-Based Stress Reduction in Prison: Experiences of Inmates, Instructors, and Prison Staff. Int J Offender Ther Comp Criminol. 2019 Nov-Dec;63(15-16):2550-2571. doi: 10.1177/0306624X19856232. Epub 2019 Jun 13.

  PMID: 31189428 BACKGROUND

• Bauml, J. M., Troxel, A., Epperson, C. N., Cohen, R. B., Schmtiz, K., Stricker, C., Shulman, L. N., Bradbury, A., Mao, J. J., & Langer, C. J. (2106). Scan-associated distress in lung cancer: Quantifying the impact of "scanxiety." Lung Cancer, 100, 110-113. https://doi.org.10.1016/j.lungcan.2016.08.002

  BACKGROUND

Study Officials

• Kimberley Roche, MSN, PPCNP-BC, APRN

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberley Roche, MSN, PPCNP-BC, APRN

CONTACT

860-545-9671; KRoche01@connecticutchildrens.org

Adam Barselau, MS

CONTACT

860-545-9671; Abarselau@connecticutchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase 1: To determine if scanxiety occurs in the caregivers of pediatric oncology patients relative to imaging studies at Connecticut Children's. Phase 2: To test whether a MBSR-influenced online intervention program decreases caregiver scanxiety.

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)