PC2122: Translation and Validation of the Chichewa Pediatric Patient-reported-outcome-ctcae Tool to Measure Treatment Related Adverse Events Among Adolescent and Young Adult Lymphoma Patients in Malawi

Background: Health related quality of life (HRQoL) is an increasingly important outcome in cancer care and research; but such data from sub-Saharan Africa (SSA) are limited. In SSA, children and adolescents diagnosed with cancer have unacceptably poor outcomes. These outcomes are in part attributable to high rates of treatment failure, a consequence of inadequate access to treatment and supportive care measures. Improving childhood cancer outcomes in resource limited settings is a major global health priority set by the World Health Organization. In resource-rich settings, patient-reported outcome (PRO) measures have emerged as a critical method to holistically understand the effects of disease and treatment on patients' mental, physical, and social HRQoL. Although these PROs measures are available for use internationally, they must first be validated, deemed culturally relevant, and methodologically sound.

Methods: The Pediatric PRO version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) includes a core 15 AE symptoms that are prevalent across pediatric cancer and treatment. Each symptom has 2-3 questions, a 4-point Likert-type scale, and a 7-day recall period. The Ped-PRO-CTCAE was translated into Chichewa and culturally validated for use in Malawi using the FACIT method. Psychometric validation was assessed using Spearman’s correlation for convergent and discriminant validity, Wilcoxon rank-sum for known group validity, and T-test for responsiveness.

Results: Fifty-Two adolescent and young adult (AYA) patients with lymphoma completed the Ped-PRO-CTCAE survey. When compared to the translated and validated Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric tool, there were stronger correlations when symptoms matched (ie pain interference r=0.57, fatigue r=0.73, depression r=0.62, and anxiety r=0.75). Known group validity testing showed that patients with poor performance status (ECOG≥2) had higher pain frequency (p < 0.001) and pain prevalence (p=0.005); and patients with anemia (hgb < 9g/dL) had worse fatigue severity (p < 0.001). Ped-PRO-CTCAE when compared to home symptom diary (ie nausea, constipation, pain, mucositis, insomnia and abdominal pain) were correlated across all matching PRO-CTCAE domains (p < 0.001). Responsiveness was supported when comparing Ped-PRO-CTCAE scores at T0 and T1 (+5 to < 21 days from T0); T1 exhibited higher mean scores associated with expected worse symptoms after chemotherapy across all fifteen PRO-CTCAE symptom AEs (p < 0.001).

Conclusion: The implementation of cutting-edge PRO measures in Malawi will allow us to holistically and comprehensively assess symptomatic adverse events (AEs) and HRQoL similar to ongoing efforts in resource-rich countries. This study found supporting evidence for the validity of the Chichewa-translated version of the Ped-PRO-CTCAE and emphasizes an urgent need to address symptomatic AEs experienced by adolescent and young adults undergoing cancer treatment in SSA.