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      Performance of the FACT-GOG-Ntx to assess chemotherapy-induced peripheral neuropathy (CIPN) in pediatric high risk Hodgkin lymphoma: report from the Children’s Oncology Group AHOD 1331 study

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          Abstract

          Background

          Chemotherapy-induced peripheral neuropathy (CIPN) is an under-recognized complication of several chemotherapy agents used as part of curative-intent therapy for Hodgkin Lymphoma (HL). In the absence of validated self- or proxy-report measures for children and adolescents, CIPN reporting has relied on clinician rating, with grading scales often restricted to severe manifestations. In a proof-of-concept study, we assessed the feasibility and psychometric performance of the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-Ntx), a unidimensional CIPN symptom scale widely used adults with CIPN, in pediatric HL at risk for CIPN.

          Methods

          Youth (11+ years) and parents of all children (5–17.9 years) with newly diagnosed high-risk HL enrolled on Children’s Oncology Group AHOD1331 (NCT02166463) were invited to complete the FACT-GOG-Ntx and a health-related quality of life (HRQL) measure at pre-treatment (Time 1), and during cycles 2 (Time 2) and 5 (Time 3) of chemotherapy during the first half of study accrual. Clinical grading of CIPN by providers was also assessed using the Balis Pediatric Neuropathy Scale. We evaluated Cronbach’s alpha, construct validity, and agreement between raters. Change in FACT-GOG-Ntx scores over time was assessed using a repeated measures model.

          Results

          306 patients had at least one completed FACT-GOG-Ntx with time-specific completion rates of > 90% for both raters. Cronbach’s alpha was > 0.7 for youth and parent-proxy report at all time points. Correlations between FACT-GOG-Ntx and HRQL scores were moderate (0.41–0.48) for youth and parent-proxy raters across all times. Youth and parent-proxy raters both reported worse FACT-GOG-Ntx scores at Time 3 for those who had clinically-reported CIPN compared to those who did not. Agreement between raters was moderate to high. Compared to baseline scores, those at Time 3 were significantly lower for youth (β = − 2.83, p < 0.001) and parent-proxy raters (β = − 1.99, p < 0.001).

          Conclusions

          High completion rates at all time points indicated feasibility of eliciting youth and parent report. Psychometric performance of the FACT-GOG-Ntx revealed acceptable reliability, evidence of validity, and strong inter-rater agreement, supporting the use of this self- or proxy-reported measure of CIPN in youth with high-risk HL exposed to tubulin inhibitors, as part of a Phase 3 clinical trial.

          Clinical trial information: Clinical Trials Registry, NCT02166463. Registered 18 June 2014, https://clinicaltrials.gov/ct2/show/study/NCT02166463

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          Most cited references32

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                Author and article information

                Contributors
                susan.parsons@tuftsmedicine.org
                Journal
                J Patient Rep Outcomes
                J Patient Rep Outcomes
                Journal of Patient-Reported Outcomes
                Springer International Publishing (Cham )
                2509-8020
                10 November 2023
                10 November 2023
                December 2023
                : 7
                : 113
                Affiliations
                [1 ]Institute for Clinical Research and Health Policy Studies and Tufts Cancer Center, Tufts Medical Center, ( https://ror.org/002hsbm82) 800 Washington Street, Boston, MA 02111 USA
                [2 ]GRID grid.15276.37, ISNI 0000 0004 1936 8091, Department of Biostatistics, Children’s Oncology Group, Statistics and Data Center, , University of Florida, ; 2004 Mowry Rd, Gainesville, FL 32610 USA
                [3 ]GRID grid.428158.2, ISNI 0000 0004 0371 6071, Department of Pediatrics, Emory University School of Medicine; Aflac Cancer and Blood Disorders Center, , Children’s Healthcare of Atlanta, ; 1405 Clifton Rd, Atlanta, GA 30322 USA
                [4 ]GRID grid.428125.8, ISNI 0000 0004 0383 0499, Department of Pediatrics, , University of Chicago Pritzker School of Medicine, Comer Children’s Hospital, ; 5721 S Maryland Ave, Chicago, IL 60637 USA
                [5 ]Department of Medical Social Sciences, Institute for Public Health and Medicine, Center for Patient-Centered Outcomes, Northwestern University, ( https://ror.org/000e0be47) 420 E. Superior St, Chicago, IL 60611 USA
                [6 ]Department of Pediatrics, Roswell Park Comprehensive Cancer Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, ( https://ror.org/01y64my43) 665 Elm St, Buffalo, NY 14203 USA
                Author information
                http://orcid.org/0000-0003-0282-6490
                Article
                653
                10.1186/s41687-023-00653-0
                10638179
                37947987
                e37dff64-4d38-437f-9305-254ab7631144
                © The Author(s) 2023

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 15 May 2023
                : 1 November 2023
                Funding
                Funded by: National Institutes of Health to the Children’s Oncology Group
                Award ID: U10CA098543
                Funded by: NCTN Statistics and Data Center Grant
                Award ID: U10CA180899
                Funded by: NCTN Operations Center Grant
                Award ID: U10CA180886
                Funded by: the NCORP grant
                Award ID: UG1CA189955
                Funded by: FundRef http://dx.doi.org/10.13039/100006058, St. Baldrick's Foundation;
                Funded by: FundRef http://dx.doi.org/10.13039/100005189, Leukemia and Lymphoma Society;
                Funded by: FundRef http://dx.doi.org/10.13039/100020124, Seagen;
                Categories
                Research
                Custom metadata
                © International Society for Quality of Life Research (ISOQOL) 2023

                chemotherapy-induced peripheral neuropathy,patient-reported outcomes,pediatric hl

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