ABSTRACT
Background: The COVID-19 pandemic (C19P) is producing several detrimental effects on cancer care globally. CT play a decisive role to provide high quality literature evidence and “poor accrual” is the most common reason for their early discontinuation (ED). At our best knowledge, no data are available on ED of prostate cancer CT after the beginning of C19P. Material and methods: ClinicalTrial.gov was queried for terminated (T), withdrawn (W) and suspended (S) CT for the following terms: “cancer”, “neoplasm” and “tumor”. CT not related on prostate cancer were excluded. The search was made for all the CT available from the inception to 26th February 2021, without any restrictions. The following characteristics were extracted: reason for ED, study type (interventional [In] vs observational), sponsor (yes vs not). ED rate was compared between CT discontinued for C19P or not (χ2);p < 0.05 was set as statistically significant. A multiple linear regression analysis was also conducted to identify independent factors of ED. Results: 9990 CT were identified and 7901 CT were excluded because not related to prostate cancer. Thus, 559 CT were included: 67% was T, 27% was W and 5% was S. Among CT classified as T, W and S, the frequency of In CT were 90%, 82% and 81% respectively, while the frequency of sponsored CT was 48%, 27% and 19% respectively. The most common reasons for ED were: “poor accrual” (31%), “lack of funding” (7%) and “sponsor decision” (5%). No reason for ED was available for 13% of CT. Ten (2%) CT were discontinued for C19P (20% was T, 10% was W and 70% was S). Comparing CT discontinued due to C19P with those discontinued due to other causes, a lower rate of In-CT (88% vs 91%, p<0.05) was found in the C19P group. At the multiple linear regression analysis, it was found that C-19 was strongly positively correlated with ED (coefficient 0,62677, p<0.0001) whereas sponsored CT resulted negatively correlated with ED (coefficient -0,03717, p=0.0369). Conclusions: “Poor accrual” continues to be the main reason for ED of cancer CT, whereas C19P represents a new additional cause of ED. Sponsored trials showed less risk for ED. Further research is needed to maximize the expected benefit of cancer CT, reducing the anticipated risks.
ABSTRACT
AIM: To develop and test the effectiveness of an E-learning program for promoting physical activity (PA) and wellness among nurses. BACKGROUND: Restrictions during the coronavirus (COVID-19) pandemic drastically changed many people's lives. Maintaining a healthy lifestyle is an everyday challenge faced by the general popula-tion. Nurses are one of the health care professionals who are typically well-educated in taking care of patients. There are studies that show that night shifts, extended shifts, and obesity have a correlation with the prevalence of acute low back pain among female nurses. PA is the key factor in the prevention and treatment of many chronic diseases, resulting in an improvement in the quality of life. The impact of social media and technology on our lives is undeniable in the modern era. DESIGN: This study will be a single-centre, single-blind, randomi-zed controlled trial executed on an E-learning platform to provide the control and intervention groups with a distance learning program. Par-ticipants will be randomly assigned to either the control or intervention group. Participants in the control group will only sign up for module 1 of the PA modules, which only comprises information on PA and health promotion. On the other hand, the participants in the intervention group are expected to carry out 3 modules of exercises at home three days a week for a total duration of 8 weeks. The exercises will be performed at moderate intensity (5-6 on the Borg CR10 Scale). ETHICAL ISSUES: This trial will comply with the declaration of Helsinki 1975, as revised in 2000. Informed written consent will be obtained from the participants. The Sapienza University of Rome, institutional ethics committee and review board approval will be requested for this study. CONCLUSION: Establishing an online PA program with good quality, such as a high level of convenience in access and use, simplified, easy to practice, and made available on social media, can minimize the difficulties faced previously in the implementation of an online PA program for nurses, and may enhance the health and wellbeing of many nurses in healthcare institutions.
Subject(s)
COVID-19 , Computer-Assisted Instruction , Nurses , Exercise , Female , Humans , Quality of Life , Randomized Controlled Trials as Topic , SARS-CoV-2 , Single-Blind MethodABSTRACT
Background: The COVID-19 pandemic (C19P) is causing several detrimental effects on cancer care globally. CT are crucial to obtain high quality literature evidence and “poor accrual” is the most common reason for their early discontinuation (ED). At our best knowledge, no data are available on ED of cancer CT after the beginning of C19P. Methods: ClinicalTrial.gov was queried for terminated (T), withdrawn (W) and suspended (S) CT for the following terms: “cancer”, “neoplasm”, and “tumor”. The search was made for all the CT available from the inception to 26th February 2021, without any restrictions. The following characteristics were extracted: reason for ED, study type (interventional [In] vs observational), sponsored (yes vs not). ED rate was compared between CT discontinued for C19P or not (χ2);p<0.05 was set as statistically significant. A multiple linear regression analysis was also conducted to identify independent factors of ED. Results: 9990 CT were identified, but 765 CT were excluded as not related to cancer. Thus, 9225 CT were included (66% was T, 23% was W and 4% was S). Among CT classified as T, W and S, the frequency of In CT was 92%, 88% and 85% respectively, while the frequency of sponsored CT was 46%, 35% and 26% respectively. The most common reasons for ED were: “poor accrual” (29%), “lack of funding” (6%) and “sponsor decision” (5%). No reason for ED was available for 15% of CT. One hundred (1%) CT were discontinued due to C19P (27% was T, 7% was W and 66% was S). Comparing CT discontinued due to C19P with those discontinued due to other reasons, a lower rate of In-CT (73% vs 91%, p<0.05) and sponsored CT (14% vs 42%, p<0.05) was found in the C19P group. At the multiple linear regression analysis, C19P was strongly positively correlated with ED (coefficient 0.59952, p<0.0001) whereas sponsored CT resulted as negatively correlated with ED (coefficient -0.02746, p<0.0001). Conclusions: “Poor accrual” continues to be the main reason for ED of cancer CT, but C19P represents a new additional cause of ED. Sponsored trials showed less risk for ED. Further research is needed to maximize the expected benefit of cancer CT, reducing the anticipated risks. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.