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

Официальное название

A Mindfulness Approach to Scanxiety

Обзор

"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.

Подробное описание

"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.

Вмешательства

• Другое 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).

Первичные конечные точки

• Likert-Style Anxiety Scale [Срок оценки: Caregivers will complete this 2 weeks before the scan.]
• State-Trait Anxiety Inventory (STAI) [Срок оценки: 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 [Срок оценки: Will be administered to caregivers in the Intervention Arm Only on Day 7.]
• Acceptability of Intervention Measure (AIM) [Срок оценки: Will be administered to both Intervention and Control Arm on both Day 1 and Day 7.]
• Intervention Appropriateness Measure (IAM) [Срок оценки: Timeframe: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.]
• Feasibility of Intervention Measure (FIM) [Срок оценки: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Connecticut Children's Medical Center — Hartford

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• Vadvilavicius T, Varnagiryte E, Jarasiunaite-Fedosejeva G, Gustainiene L. The Effectiveness of Mindfulness-Based Interventions for Police Officers' Stress Reduction: a Systematic Review. J Police Crim Psychol. 2023;38(1):223-239. doi: 10.1007/s11896-022-09570-2. Epub 2023 Jan 30. PMID 36741275
• 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.

Идентификаторы

NCT: NCT07420101 · 24-135

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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