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
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 re...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2023-11-01
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| Series: | Journal of Patient-Reported Outcomes |
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| Online Access: | https://doi.org/10.1186/s41687-023-00653-0 |
| _version_ | 1797630198737272832 |
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| author | Susan K. Parsons Angie Mae Rodday Qinglin Pei Frank G. Keller Yue Wu Tara O. Henderson David Cella Kara M. Kelly Sharon M. Castellino |
| author_facet | Susan K. Parsons Angie Mae Rodday Qinglin Pei Frank G. Keller Yue Wu Tara O. Henderson David Cella Kara M. Kelly Sharon M. Castellino |
| author_sort | Susan K. Parsons |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-03-11T11:04:47Z |
| format | Article |
| id | doaj.art-dae90ca588e241778004915435ffdab9 |
| institution | Directory Open Access Journal |
| issn | 2509-8020 |
| language | English |
| last_indexed | 2024-03-11T11:04:47Z |
| publishDate | 2023-11-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Journal of Patient-Reported Outcomes |
| spelling | doaj.art-dae90ca588e241778004915435ffdab92023-11-12T12:19:27ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202023-11-017111210.1186/s41687-023-00653-0Performance 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 studySusan K. Parsons0Angie Mae Rodday1Qinglin Pei2Frank G. Keller3Yue Wu4Tara O. Henderson5David Cella6Kara M. Kelly7Sharon M. Castellino8Institute for Clinical Research and Health Policy Studies and Tufts Cancer Center, Tufts Medical CenterInstitute for Clinical Research and Health Policy Studies and Tufts Cancer Center, Tufts Medical CenterDepartment of Biostatistics, Children’s Oncology Group, Statistics and Data Center, University of FloridaDepartment of Pediatrics, Emory University School of Medicine; Aflac Cancer and Blood Disorders Center, Children’s Healthcare of AtlantaDepartment of Biostatistics, Children’s Oncology Group, Statistics and Data Center, University of FloridaDepartment of Pediatrics, University of Chicago Pritzker School of Medicine, Comer Children’s HospitalDepartment of Medical Social Sciences, Institute for Public Health and Medicine, Center for Patient-Centered Outcomes, Northwestern UniversityDepartment of Pediatrics, Roswell Park Comprehensive Cancer Center, University at Buffalo Jacobs School of Medicine and Biomedical SciencesDepartment of Pediatrics, Emory University School of Medicine; Aflac Cancer and Blood Disorders Center, Children’s Healthcare of AtlantaAbstract 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/NCT02166463https://doi.org/10.1186/s41687-023-00653-0Chemotherapy-induced peripheral neuropathyPatient-reported outcomesPediatric HL |
| spellingShingle | Susan K. Parsons Angie Mae Rodday Qinglin Pei Frank G. Keller Yue Wu Tara O. Henderson David Cella Kara M. Kelly Sharon M. Castellino 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 Journal of Patient-Reported Outcomes Chemotherapy-induced peripheral neuropathy Patient-reported outcomes Pediatric HL |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Chemotherapy-induced peripheral neuropathy Patient-reported outcomes Pediatric HL |
| url | https://doi.org/10.1186/s41687-023-00653-0 |
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