The impact of telemonitoring on correct drug use, complications and quality of life among patients with multiple myeloma (ITUMM): A study protocol for an open-label, parallelgroup, randomized controlled trial

Abstract

Introduction Multiple myeloma (MM) is the second most common hematologic malignancy. MM is associated with significant morbidity due to its end-organ destruction and is a disease of the older population. Although survival rates for MM have improved over the last decade, due to an increase in treatment options, the disease remains incurable. Expensive (oral) agents are widely used in MM patients; however, tools for supporting patients in complex treatment regimens are scarce. To investigate if a tool will support MM patients and healthcare professionals, the MM e-coach was developed and tested. The aim of this study is to study the impact of telemonitoring on adherence, complications and quality of life in patients with MM (ITUMM study). Methods A two-arm open-label parallel-group randomized controlled trial will be conducted between March 2021 and June 2024 to compare the telemonitoring (MM e-coach) with standard MM care. This study aimed to recruit 150 patients with recently diagnosed multiple myeloma (RDMM), starting first or second line of treatment. Blinded primary outcome is adherence by pill count after start of treatment at 1-3 months. Secondary outcomes are patient reported outcomes: GFI, EQ-5D-5L, EORTC-QLQ-C30, SDM-Q-9, MARS-5, single item questions, PREMs, adverse events, OS and PFS. Patient reported outcomes were developed and integrated in the e-coach MM to regularly measure digitized outcomes of MM patients from time of RDMM until 12 months post-diagnosis. Online measurements will be performed at baseline (0), 3, 6, 9 and 12 months. Ethics and dissemination Ethics approval has been granted by the Ethics Committee of the Isala klinieken in The Netherlands (No. 201111) at 25 February 2021. Study results will be disseminated to the relevant healthcare communities by publication in peer-reviewed journals, and at scientific and clinical conferences.