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| Name | Class |
|---|---|
| Connecticut Children's Medical Center | OTHER |
| UConn Health | OTHER |
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"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.
"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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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).](streamdown:incomplete-link) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberley Roche, MSN, PPCNP-BC, APRN | Contact | 860-545-9671 | KRoche01@connecticutchildrens.org | |
| Adam Barselau, MS | Contact | 860-545-9671 | Abarselau@connecticutchildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Kimberley Roche, MSN, PPCNP-BC, APRN | Connecticut Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Recruiting | Hartford | Connecticut | 06106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37713902 | Background | 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. | |
| 30020672 | 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/ |
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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.
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| 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. |
| 35213264 | 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. |
| 37186462 | 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. |
| 32477199 | 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. |
| 25701663 | 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. |
| 36741275 | Background | 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. |
| 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. |
| 37444606 | 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. |
| 31501961 | 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. |
| 33120117 | 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. |
| 32989406 | 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. |
| 28702717 | Background | Freedenberg VA, Hinds PS, Friedmann E. Mindfulness-Based Stress Reduction and Group Support Decrease Stress in Adolescents with Cardiac Diagnoses: A Randomized Two-Group Study. Pediatr Cardiol. 2017 Oct;38(7):1415-1425. doi: 10.1007/s00246-017-1679-5. Epub 2017 Jul 12. |
| 36900174 | Background | Derry-Vick HM, Heathcote LC, Glesby N, Stribling J, Luebke M, Epstein AS, Prigerson HG. Scanxiety among Adults with Cancer: A Scoping Review to Guide Research and Interventions. Cancers (Basel). 2023 Feb 22;15(5):1381. doi: 10.3390/cancers15051381. |
| 34039571 | 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. |
| 31189428 | 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. |
| 27597289 | Background | Bauml JM, Troxel A, Epperson CN, Cohen RB, Schmitz K, Stricker C, Shulman LN, Bradbury A, Mao JJ, Langer CJ. Scan-associated distress in lung cancer: Quantifying the impact of "scanxiety". Lung Cancer. 2016 Oct;100:110-113. doi: 10.1016/j.lungcan.2016.08.002. Epub 2016 Aug 16. |