International Nutrition Audit in FORegut TuMors

Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:19 - Any
Start Date:July 26, 2016
End Date:July 31, 2019
Contact:Rupinder Dhaliwal, RD, FDC

Use our guide to learn which trials are right for you!

International Audit of Nutrition Care in Patients With FORegut TuMors

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.

Inclusion Criteria:

1. Patients with Head and Neck or Esophageal Cancer and

2. At least 18 yrs age.

Exclusion Criteria:

1. At the time of diagnosis of cancer, if there is no treatment plan due to patient's
imminent death OR

2. At the time of diagnosis of cancer, patient's Eastern Cooperative Oncology Score
(ECOG) score is ≥ 4
We found this trial at
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
Sacramento, CA
Click here to add this to my saved trials
119-143 Missenden Road
Camperdown, New South Wales 2050
Click here to add this to my saved trials