|drug3121||Shared Decision Making Wiki||0.50|
|drug1716||Intracorporeal left hemicolectomy anastomosis Wiki||0.50|
|drug1086||Dornase Alfa Inhalation Solution Wiki||0.50|
There are 4 clinical trials
The study is a cross-sectional survey study targeting patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Study staff will survey a random subsample of patients to assess anxiety, COVID risk tolerance, cancer worry, willingness to screen and barriers to screening colonoscopy, and preference for colonoscopy and alternative colon cancer screening options. Eligible patients will be sent a survey packet in the mail that will include a cover letter, an information sheet describing the study, an incentive, and the survey. The cover letter will include information for participants to opt-out if they desire. Patients will be asked to complete the survey and return it back to study staff. Consent is implied with return of the survey. For the study, staff plan to invite 300 patients and expect to receive 195 completed surveys. Analyses will examine whether COVID-19 has changed patients' interest in colon cancer screening and the strength of patients' preferences for colonoscopy and other approaches to colon cancer screening. It will then examine factors associated with positive and negative views on rescheduling colonoscopies such as anxiety, worry, and risk perceptions.
Description: Item with 5-point response assessing whether COVID-19 has increased, decreased or not changed interest in colon cancer screeningMeasure: Interest in colon cancer screening Time: at start of study--between one week and 2 months after start of study
Description: Item with 5-point response (definitely want to definitely do not want) measuring interest in having a stool test for colon cancerMeasure: Preference for stool testing Time: at start of study--between one week and 2 months after start of study
Description: Item with 5-point response (definitely want to definitely do not want) measuring interest in postponing colonoscopy for one yearMeasure: Preference for postponing colonoscopy for one year Time: at start of study--between one week and 2 months after start of study
Description: Item with 5 point response (extremely worried to not at all worried) assessing worry about the delay of the colonoscopy on their colon cancer riskMeasure: Worry about delay Time: at start of study--between one week and 2 months after start of study
Description: Item with 5-point response (very high to very low) assessing patients' perception about risk of getting COVID-19 from having a colonoscopyMeasure: Risk perception on COVID-19 Time: at start of study--between one week and 2 months after start of study
OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage. BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible. Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis. METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.
Description: Percentage of anastomic leak (defined in accordance with Peel et al.).Measure: Percentage of anastomotic leak (AL) Time: 30 days
Description: Dindo-Clavien ClassificationMeasure: Rate of global morbidity Time: 30 days
Description: SSI in accordance with the Center for Disease Control (CDC) NationalMeasure: Rate of Surgical site infection Time: 30 days
Description: Percentage of re-interventions due to surgical complicationsMeasure: Rate of Re-interventions Time: 30 days
The global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (WHO), with a trend of ongoing growth. This very frequent illness exerts tremendous physical, emotional and financial strain on individuals, families, communities and health systems. Malnutrition (under- or over-nutrition) is highly prevalent in cancer patients receiving chemotherapy and is an important predictor of morbidity, mortality, treatment response and toxicity. Alterations in taste and smell are frequently reported as side effect of chemotherapy and may contribute strongly to malnutrition and to a worsen quality of life and wellbeing social, emotional, and role functioning. There are evidences that chemotherapy influences food liking and appetite with implications for food behaviours, including food enjoyment, food preference and dietary intake. A linkage between alterations in taste and /or smell and food behaviours has been reported by some studies but not all, suggesting that there is a need for more research using common standardised methodologies and larger sample size to gain a further insight into this topic.
Description: To better understand alteration of taste/smell and food behaviours by the self-report responses, using an adapted version of a questionnaire set up to measure taste changes due to COVID-19Measure: change of taste chemotherapy-related alterations Time: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)
Description: Emotions elicited by foods will be measured on a selection of foods through an EmoSemio questionnaire, a self-report measure of emotion developed based on preliminary interviewsMeasure: Emotions elicited by foods Time: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)
The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.
Description: short patient reported scale asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4 with higher scores indicating higher shared decision making.Measure: Shared Decision Making (SDM) Process Scale Score Time: 6 weeks after intervention
Description: the 4-item version of the decisional conflict scale, total score ranges from 0-4 with greater scores indicating less decisional conflict.Measure: Decisional Conflict (SURE scale) Time: 6 weeks after intervention
Description: One item will assess patients' preferred approach to screening (with responses of colonoscopy, stool card test, no screening, not sure).Measure: Patient's preferred approach to screening Time: 6 weeks after intervention
Description: One item will assess patients' intention to follow through with their preferred approach on a 5-point scale from not at all likely to extremely likely.Measure: Intention to screen Time: 6 weeks after intervention
Description: Percentage of patients who had completed colon cancer screening testMeasure: Colon cancer screening rate Time: 6 months after randomization
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports