To the Editor,The new coronavirus disease 2019 (COVID‐19) pandemic has been impairing the diagnosis and treatment of cancer. Moreover, the value of some compulsory practices in clinical trials, such as multiple clinical visits in asymptomatic patients are now subjected to scrutiny. 1
According to the World Health Organization, Brazil is the second country in the number of cases and deaths by COVID‐19 disease. 2 In this scenario, new approaches have been implemented to mitigate the impact of COVID‐19 in research for the involved health professionals and also for the patients. Our aim was to evaluate the value of telemedicine for maintenance of scheduled follow‐up in a cancer clinical trial (NCT3366051) 3 during the pandemic.
A prospective randomized non‐inferiority clinical trial is being carried out, 3 where patients with endometrial cancer are being randomized for sentinel lymph node mapping with or without systematic lymphadenectomy for staging purpose. The primary endpoint is recurrence free survival in 3 years and secondary endpoints overall survival, quality of life (QoL), and complication rates. The complications are being classified by the Radiation Therapy Oncology Group and Common Toxicity Criteria Adverse events 5.0 criteria. The study comprises the application of QoL questionnaires EORTC QLQ30 and Cx24 preoperatively and after 1, 6, and 12 months of follow‐up. Lower limb lymphedema is also evaluated by circumference measurement. Loss of follow‐up was considered as visit scheduled in other period, absence of any scheduled visit, and refusal to answer the questionnaires.
After the pandemic onset, from May and June 2020, the patients who had their visits delayed were contacted by phone call for symptoms evaluation, screening of complications and treatment toxicity, and application of QoL questionnaire EORTC‐QLQ30. Yet, we used the validated patient report outcomes for lymphedema analysis.
A total of 107 women entered the clinical trial before the pandemic onset, from December 2017 to February 2020. The overall compliance of follow‐up for all scheduled visits and QoL assessment was 58%. After the pandemic onset, the follow‐up strategy included telemedicine. Of the 26 women that had contact attempted by telemedicine, it succeeded in 23 (88.5%) cases. The postoperative follow‐up time were done in 1, 6 and 12 months for 3 (13%), 11 (47.8%), and 9 (39.1%) patients, respectively. Although analyzing only a single contact, we found higher compliance rates for telemonitoring compared to overall standard visits (88.5% vs. 58%).
Moreover, telemonitoring was reported by the patients as an opportunity to solve doubts about pandemic and their medical conditions. Only one (4.3%) case described a discomfort in reporting her clinical data by phone call.
Telemedicine emerged as a reliable tool during pandemic not just for patient's consultation but also for follow‐up, as clinically excessive visits may increase the exposure and contagious risk for patients and providers. 4 Although not underscoring the importance of physical examination in gynecological cancer, telemedicine emerges as a feasible and reliable method for patients' follow‐up in clinical trials even outside the pandemic scenario, increasing the compliance of follow‐up and survey application. 1
In a landmark clinical trial of cervical cancer, the compliance rate of at least one QoL survey was 79%, showing the difficulty on this issue. 5 Notably, even during the pandemic, we found a potentially better patients' compliance with telemedicine compared to our previous experience.
Although the main study weakness is the relatively small number of patients, our findings may contribute to literature in this topic. In conclusion, our study suggests that telemedicine may have an important role in monitoring patients included in clinical trials during the COVID‐19 pandemic.
CONFLICT OF INTERESTS
The author declares that there are no conflict of interests.
REFERENCES
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