H. Lee Moffitt Cancer Center and Research Institute/University of South Florida Morsani, Tampa, FL
Gabriel Roman Souza , Mahati Paravathaneni , Filip Ionescu , Keerthi Gullapalli , Sarah Raymond , Ghazal Jameel , Juskaran Chadha , Rohit K. Jain , Gillian Trujillo , Amayla M. Budet DeJesus , Brandon J. Manley , Amy Schneider , Youngchul Kim , Adele Semaan , Heather S.L. Jim , Philippe E. Spiess , Jad Chahoud
Background: Renal Cell Carcinoma (RCC) is a global public health burden with over 400,000 new cases and over 175,000 deaths annually. Immune checkpoint inhibitors (ICI) in combination with vascular endothelial growth factor tyrosine kinase inhibitors (VEGF-TKI) has become an integral part of the management of patients with advanced RCC which requires adaptation of healthcare systems to provide information and optimize the management of drug-related adverse events. This study aims to improve the education on therapy-related symptoms and the quality of life of patients with RCC treated with these drugs. Methods: We created a smartphone application (mHealth) that combines educational data, patient-reported outcomes, and peer-to-peer interactions. We aim to assess the feasibility of expansion of this pilot study. We prospectively enrolled stage IV RCC patients (n=20) undergoing treatment with combination ICI and VEGF-TKI. Therapy-related symptom education, knowledge PRO questionnaires, and peer-to-peer support were provided at baseline and at different time points throughout this study duration (Table 1). Time-course data of PROs were visualized using line plots and then compared with paired t-tests. The study's primary endpoint was to assess acceptability and feasibility of mHealth, defined as acceptable if 50% of patients offered participation agree to be enrolled and feasible if 50% of enrolled patients complete the intervention with 70% of these completing at least 50% of survey instruments. Results: Eighty percent of patients were male, 80% were white, 75% had at least some college education, 70% were married, and the mean age of the cohort was 66 years.A total of 22 patients were approached for the study with an acceptance rate of 90%. Sixty percent of patients completed every questionnaire and knowledge assessment at every timepoint of the intervention and 75% of those completed at least 50% of instruments. PROs data showed no significant difference compared to baseline in global health status, functional scales, and symptom scales across the 24 weeks. We noticed an improvement in the patients' knowledge assessment on symptom management after completion of the mHealth knowledge component. Conclusions: Our pilot study was considered acceptable and feasible, showing preliminary evidence of improvement in patient knowledge with mHealth. Our future direction will be to assess, in a larger randomized study, the efficacy of mHealth in improving the quality of life of patients with advanced RCC treated with ICI and VEGF-TKI. Clinical trial information: NCT05579847.
Instrument | Baseline | 3w | 4w | 6w | 8w | 12w | 16w | 20w | 24w |
---|---|---|---|---|---|---|---|---|---|
Screening and eligibility form | X | ||||||||
Patient enrollment survey | X | ||||||||
Educational component | Over 6 weeks | ||||||||
Knowledge assessment | X | X | X | X | |||||
PRO instruments | X | X | X | X | X | X | X | ||
Peer-to-peer component | Over 24 weeks |
Abbreviations: w, weeks; PRO, patient-reported outcomes.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2024 ASCO Genitourinary Cancers Symposium
First Author: Thomas Powles
2023 ASCO Quality Care Symposium
First Author: Laura A Petrillo
2022 ASCO Quality Care Symposium
First Author: Stephen Huo
2023 ASCO Annual Meeting
First Author: Laura A Petrillo