ABSTRACT
Background: In December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detected for the first time in Wuhan, China, causing the coronavirus disease 2019 (COVID-19). Mortality rate in patients with multiple myeloma (MM) hospitalized due to COVID-19 has been reported to be 50% higher compared to non-cancer patients. The COVID-19 pandemic has resulted in adaption of myeloma care recommendations including key principles of limiting hospital visits by use of telemedicine communication and to use oral agents as much as possible and/or allowing treatment breaks. To mitigate the risk of COVID-19 spreading, extensive national lockdowns have been practiced and patients and caregivers have been encouraged to practice social distancing. Aims: The aim was to investigate the impact of the first and second wave of the COVID-19 pandemic on quality of life (QoL) in Danish patients with MM. Methods: The study was designed as a cross-sectional study comparing QoL in patients with MM using data obtained the year before the pandemic (pre-COVID) as a reference in comparison to the COVID period. In a Danish context, first wave was defined as April to June 2020 and the second wave as November 2020 to January 2021. The survey data originates from an ongoing cohort study, "Quality of life in Danish Multiple Myeloma patients" (QoL-MM), which is a Danish prospective, nationwide, observational survey, initiated in February 2017. Survey data are obtained at enrolment and subsequently at 12 follow-up time points over a two-year period including 24 QoL domains assessed by the European Organisation for Research and Treatment of Cancer Quality of life QLQC30, the Multiple Myeloma module QLQ-MY20, the Chemotherapy- Induced Peripheral Neuropathy module and the Short-form health survey version 2. The QoL data was analysed using mixed effects linear regression, with a year-period-interaction. Pre-COVID versus COVID mean domain score difference was considered evident, if the difference was both statistically significant (p-value <0.05) and clinical relevant using minimal important difference defined as 0.3 standard deviation of the mean score of all included 2019 answers. For data validation, the mean scores of the pre-COVID period were compared to the mean scores for 2018. Results: In the study, 616 patients was included (63% newly diagnosed and 37% relapsed) with a mean age of 68.2 years (standard deviation 9.2). Females represent 40% of the population. Seventy-six percent were married/ cohabiting, 24% single. The completion rates during the investigated periods were between 94% to 97%, and a total of 2,576 completed sets of questionnaires were included in the analyses. The Danish MM patients reported no statistical significant and clinical relevant difference in QoL during the first or second wave of the COVID-19 pandemic compared to one year earlier. Summary/Conclusion: Patients with MM infected by COVID-19 are in increased risk of dying and the pandemic has to some extent affected the usual clinical care program and caused restrictions in their everyday living. However, the pandemic does not seem to impact the patients′ reporting's of QoL. A limitation, however, may be that the questionnaires used are not validated to capture psychosocial health during a pandemic. Still, our results is important as it documents that QoL collected in clinical trials during the pandemic allow interpretation without adjusting for the impacts of the pandemic.