An intervention for Fear of Progression in Childhood Cancer Patients and their Parents: Results of a Pilot Randomized Trial

An intervention for Fear of Progression in Childhood Cancer Patients and their Parents: Results of a Pilot Randomized Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article An intervention for Fear of Progression in Childhood Cancer Patients and their Parents: Results of a Pilot Randomized Trial Jessy Herrmann, Laura Kern, Anja Santel, Leonard Konstantin Kulisch, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4501631/v4 This work is licensed under a CC BY 4.0 License Status: Posted Version 4 posted You are reading this latest preprint version Show more versions Abstract Background : Fear of progression (FoP) is a significant psychosocial burden for children with cancer and their parents, influencing their quality of life (HRQoL) and emotional adjustment. There is a lack of helpful therapeutic interventions in pediatric oncology. We have developed the family-based intervention “Kinder-Progredienzangst” (KIPA, engl.: children FoP) and investigated its feasibility and efficacy. Methods : In this pilot randomized controlled trial (RCT) 29 families with a child diagnosed with cancer and undergoing acute treatment or follow-up care participated. Eligibility criteria included moderate or high FoP in at least one family member. Families were randomized to either an intervention group or a waitlist-control group receiving treatment as usual. KIPAconsists of psychoeducation, anxiety confrontation, and resource activation. Participants completed questionnaires for FoP, anxiety, depression, HRQoL, and posttraumatic stress symptoms (PTSS) at different time points. The aim of the study was to assess participation and retention rates as well as the efficacy of KIPA. We used Mann-Whitney U tests for between-group comparisons, Friedman and Wilcoxon tests for within-group comparisons and Hedges g for effect sizes. Results : Feasibility results showed a participation rate of 23%, with higher participation in acute treatment (51%) compared to follow-up care (15%). Retention rates were 71% overall, with significant variability between settings. Efficacy analyses revealed significant differences in parental FoP between study conditions with high effect size ( W =65.5, p =.023, g =-0.855). Improvements were also noted in PTSS ( W =33, p <.001, g =-1.365), anxiety ( W =59, p =.017, g =-0.906) and mental ( W =217, p <.001, g =1.619) and physical ( W =180, p =.042, g =0.834) HRQoL. The pre-post analysis showed a significant reduction in parental FoP in both settings, and the follow-up data indicate sustainability. Effects on children’s FoP were less pronounced, with trends suggesting indirect benefits from reduced parental distress. Conclusion : KIPA demonstrates feasibility and promising efficacy in reducing FoP among parents of pediatric oncology patients. The findings highlight the challenges of enrollment, particularly in children, and the importance of considering family dynamics. Future research should focus on optimising recruitment strategies and evaluating effects in larger multicenter trials. The trial was retrospectively registered at the German Trail Registry (TRN: DRKS00024106, 04.05.2022). Fear of Progression Cancer Pediatrics Intervention Feasibility Figures Figure 1 Figure 2 Figure 3 Full Text Additional Declarations The authors declare no competing interests. Supplementary Files Addfile1ContentKIPA.xlsx ContentKIPA Cite Share Download PDF Status: Posted Version 4 posted You are reading this latest preprint version Show more versions Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4501631","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":398542308,"identity":"b274783b-3d0f-498b-96d3-c520460fcc21","order_by":0,"name":"Jessy 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1","display":"","copyAsset":false,"role":"figure","size":217353,"visible":true,"origin":"","legend":"\u003cp\u003eDesign of the KIPA-Study\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4501631/v4/d0c9d89ed84a61da04fe9cab.jpg"},{"id":75059640,"identity":"2bcd6d90-f086-4d42-ad8c-c9e8de3dd48e","added_by":"auto","created_at":"2025-01-30 03:41:40","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":813768,"visible":true,"origin":"","legend":"\u003cp\u003eFlow-chart for participation and drop-out\u003c/p\u003e","description":"","filename":"Fig2FlowChart.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4501631/v4/4050401f324763939cb3944e.jpg"},{"id":75059761,"identity":"87dba004-532d-43c9-bdb1-771580c32150","added_by":"auto","created_at":"2025-01-30 03:49:40","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":125742,"visible":true,"origin":"","legend":"\u003cp\u003eCourse of FoP (M, 95% CI) in parents and children\u003c/p\u003e","description":"","filename":"Fig3CourseFoPneu.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4501631/v4/ef96b0ed827e98422c60efcf.jpg"},{"id":75059076,"identity":"8d785f67-00b5-42fd-80f2-473827aa65dd","added_by":"auto","created_at":"2025-01-30 03:33:40","extension":"xlsx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":14319,"visible":true,"origin":"","legend":"\u003cp\u003eContentKIPA\u003c/p\u003e","description":"","filename":"Addfile1ContentKIPA.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-4501631/v4/42c0e3aca1a45a2ba3f828ad.xlsx"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"An intervention for Fear of Progression in Childhood Cancer Patients and their Parents: Results of a Pilot Randomized Trial","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Fear of Progression, Cancer, Pediatrics, Intervention, Feasibility","lastPublishedDoi":"10.21203/rs.3.rs-4501631/v4","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4501631/v4","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Fear of progression (FoP) is a significant psychosocial burden for children with cancer and their parents, influencing their quality of life (HRQoL) and emotional adjustment. There is a lack of helpful therapeutic interventions in pediatric oncology. We have developed the family-based intervention “Kinder-Progredienzangst” (KIPA, engl.: children FoP) and investigated its feasibility and efficacy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: In this pilot randomized controlled trial (RCT) 29 families with a child diagnosed with cancer and undergoing acute treatment or follow-up care participated. Eligibility criteria included moderate or high FoP in at least one family member. Families were randomized to either an intervention group or a waitlist-control group receiving treatment as usual. KIPAconsists of psychoeducation, anxiety confrontation, and resource activation. Participants completed questionnaires for FoP, anxiety, depression, HRQoL, and posttraumatic stress symptoms (PTSS) at different time points. The aim of the study was to assess participation and retention rates as well as the efficacy of KIPA. We used Mann-Whitney \u003cem\u003eU\u003c/em\u003e tests for between-group comparisons, Friedman and Wilcoxon tests for within-group comparisons and Hedges \u003cem\u003eg\u003c/em\u003e for effect sizes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Feasibility results showed a participation rate of 23%, with higher participation in acute treatment (51%) compared to follow-up care (15%). Retention rates were 71% overall, with significant variability between settings. Efficacy analyses revealed significant differences in parental FoP between study conditions with high effect size (\u003cem\u003eW\u003c/em\u003e=65.5, \u003cem\u003ep\u003c/em\u003e=.023, \u003cem\u003eg\u003c/em\u003e=-0.855). Improvements were also noted in PTSS (\u003cem\u003eW\u003c/em\u003e=33, \u003cem\u003ep\u003c/em\u003e\u0026lt;.001, \u003cem\u003eg\u003c/em\u003e=-1.365), anxiety (\u003cem\u003eW\u003c/em\u003e=59, \u003cem\u003ep\u003c/em\u003e=.017, \u003cem\u003eg\u003c/em\u003e=-0.906) and mental (\u003cem\u003eW\u003c/em\u003e=217, \u003cem\u003ep\u003c/em\u003e\u0026lt;.001, \u003cem\u003eg\u003c/em\u003e=1.619) and physical (\u003cem\u003eW\u003c/em\u003e=180, \u003cem\u003ep\u003c/em\u003e=.042, \u003cem\u003eg\u003c/em\u003e=0.834) HRQoL. The pre-post analysis showed a significant reduction in parental FoP in both settings, and the follow-up data indicate sustainability. Effects on children’s FoP were less pronounced, with trends suggesting indirect benefits from reduced parental distress.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e: KIPA demonstrates feasibility and promising efficacy in reducing FoP among parents of pediatric oncology patients. The findings highlight the challenges of enrollment, particularly in children, and the importance of considering family dynamics. Future research should focus on optimising recruitment strategies and evaluating effects in larger multicenter trials.\u003c/p\u003e\n\u003cp\u003eThe trial was retrospectively registered at the German Trail Registry (TRN: DRKS00024106, 04.05.2022).\u003c/p\u003e","manuscriptTitle":"An intervention for Fear of Progression in Childhood Cancer Patients and their Parents: Results of a Pilot Randomized Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":4,"date":"2025-01-30 03:33:35","doi":"10.21203/rs.3.rs-4501631/v4","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}},{"code":3,"date":"2025-01-06 23:27:49","doi":"10.21203/rs.3.rs-4501631/v3","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}},{"code":2,"date":"2024-08-15 19:13:35","doi":"10.21203/rs.3.rs-4501631/v2","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}},{"code":1,"date":"2024-07-29 18:14:15","doi":"10.21203/rs.3.rs-4501631/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3ab762f4-d10b-47ec-9266-7c82bb6be3c4","owner":[],"postedDate":"January 30th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-10-06T20:23:18+00:00","versionOfRecord":[],"versionCreatedAt":"2025-01-30 03:33:35","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v4","identity":"rs-4501631","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4501631","identity":"rs-4501631","version":["v4"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}