Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Cancer

Leah Gramlich, MD, FRCP

The purpose of this study is to evaluate the current state of nutrition care and patient related outcomes in patients with head, neck and esophageal cancers in North America, Europe and Australia.

The proposed project is a prospective inception cohort study of current nutrition practices of patients with foregut tumors (esophageal and/or head \& neck cancer) in cancer care settings in Canada, Europe and Australia. This multi center study will involve a baseline audit of current nutrition practice, followed by repeated audit cycles for up to 6 months from the first time the patient is introduced to the Cancer Care System. Approximately 5-7 Cancer Care settings from Europe, Australia and North America will participate in this audit.

All consecutive consenting patients will be enrolled in the study. As an audit, a formal sample size calculation is not possible, however, we estimate that each of the 5-7 sites will be able to enroll 20 patients over 1 year, with a 6 month follow up, resulting in an estimated sample size of 140-200. All the nutrition care characteristics, patient level descriptors and patient related outcomes will be described using mean and standard deviation or median and inter quantile range based on distributional properties for continuous variables by different locations and cancer care settings. Count with percentages will be used for categorical variables. The effect of route of nutrition, timing of initiation of nutrition intervention, adequacy of nutrition, Patient Generated Subjective Global Assessment (PGSGA) scores and scores of weight, food intake, symptoms and activities \& function on survival of the patients will be assessed by univariate and multi-variable Cox regression.

The association of categorical factors such as route of nutrition, timing of initiation of nutrition intervention and so on with the categorical outcomes-complications related to cancer treatment, unplanned readmission and treatment toxicity-will be assessed by chi-square or Fisher exact test, as appropriate. The continuous variables such as PGSGA and other scores will be compared between different categories of the outcomes by t-test or ANOVA as appropriate. Appropriate non-parametric test will be conducted if distributional properties invalidate the use of t-test or ANOVA. The association of continuous variables with continuous outcomes will be assessed by Pearson or Spearman correlation. If necessary, multivariable analyses will be conducted using multiple regression analysis for continuous outcomes and logistic regression for binary outcomes.

Data will be stored in REDCap system housed in a physically and electronically secure data centre at the University of Alberta and is behind the Faculty of Medicine's firewall. REDCap is a secure, web-based application designed exclusively to support data capture for research studies. REDCap provides: 1) an intuitive interface for data entry (with data validation); 2) 128 bit encryption between the data entry client and the server; 3) audit trails for tracking data manipulation and export procedures; 4) automated export procedures for seamless data downloads to common statistical packages (SPSS, Statistical Analysis Software \[SAS\], Stata, R); 5) procedures for importing data from external sources; and 6) advanced features, such as branching logic, calculated fields and data quality checks.

After this pilot study is completed, we hope to enhance the nutrition evidence in this area by expanding this work to create a prospective registry of nutrition practices and outcomes in patients with foregut tumors.

International Nutrition Audit in FORegut TuMors

International Audit of Nutrition Care in Patients With FORegut TuMors

Only the aggregate of all anonymous participant data will be shared with the participating sites upon request. The site specific anonymous participant data will be shared with the site upon request. This is detailed in the Data Transfer Agreement with each site.

What is the timing of start of nutrition, adequacy of nutrition and the route of nutrition (oral, enteral and/or parenteral)

Does the route of nutrition (oral, enteral, if enteral either gastric or jejunal or parenteral) correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity

Does the timing of initiation of nutrition intervention correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity

Does the adequacy of nutrition intervention correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity

Does the PGSGA correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity

Fresenius Kabi

Nutricia Advanced

Baxter Healthcare Corporation

University of Alberta

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Audit

Aliae Mohamed-Hussein, MD

The investigators will conduct nationally representative survey in chest physicians in Egypt in 2016-2017. Self-administered questionnaire will be used to assess the physicians' knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or sputum cytology in the past 12 months.

Although current practice guidelines do not recommend screening asymptomatic patients for lung cancer, physicians may still order lung cancer screening tests. No recent national survey of health care professionals has focused on lung cancer screening

Audit of Lung Cancer Screening Practice in Chest Physicians: An Update

Lung Cancer Screening Practice in Chest Physicians

Assiut University

Prof. Dr. Aliae AR Mohamed-Hussein, Professor of Pulmonology

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Amine Benkabbou, Pr

Raouf Mohsine, Pr

Abdelmalek Hrora, Pr

Surgery for digestive cancers is managed according to quality standards, validated by the scientific community. Despite the diffusion of these standards through the benchmarks of good practice, the results of the surgery remain disparate.

In many countries, this "inequality of opportunity" has justified the establishment of quality assurance systems to measure the results of surgery for one or more localizations of digestive cancer.

These surgical audit experiments have shown a positive, rapid and cost-effective impact on complication rates, recurrence rates and overall survival even in the absence of interventional measures. The data collected also helped to improve the management of subgroups of patients usually excluded from clinical trials.

In Morocco, the National Cancer Prevention and Control Plan provides for the establishment of a quality assurance system with the introduction of a system for monitoring and evaluating the care of patients. This pilot project is part of this framework, for the group of patients who are candidates for surgery for digestive cancers.

Observatory of the Quality of Surgical Procedures for Digestive Cancers

Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.

Death within 90 days of surgical procedure

Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure

Overall survival is defined as time from initiation to death of any cause within 3years of surgical procedure

Disease free survival is defined as time from initiation to death of any cause within 3years of surgical procedure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
International Nutrition Audit in FORegut TuMors	NCT02829489	Head and Neck C... Esophageal Canc...		19 Years -	University of Alberta
Audit of Lung Cancer Screening Practice in Chest Physicians: An Update	NCT02944903	Lung Cancer Scr...	Audit	-	Assiut University
International Nutrition Audit in FORegut TuMors	NCT02829489	Head and Neck C... Esophageal Canc...		19 Years -	University of Alberta
Audit of Lung Cancer Screening Practice in Chest Physicians: An Update	NCT02944903	Lung Cancer Scr...	Audit	-	Assiut University
Observatory of the Quality of Surgical Procedures for Digestive Cancers	NCT03681600	Digestive Syste... Surgery Surgery--Compli... Quality of Heal... Medical Audit		16 Years -	Moroccan Society of Surgery

Spots Global Cancer Trial Database for audit

Every month we try and update this database with for audit cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for audit

Every month we try and update this database with for audit cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for audit cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.