Clinical trial NCT02829489: International Nutrition Audit in FORegut TuMors
Official title: International Audit of Nutrition Care in Patients With FORegut TuMors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Esophageal Cancer
Keywords: nutrition
foregut tumors
patient related outcomes
audit
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi
name: Nutricia Advanced
name: Baxter Healthcare Corporation
First posted: 2016-07-12
Enrollment: 170
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with head and/or neck cancer or esophageal cancer

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Delivery of nutrition intervention
timeFrame: up to a maximum of 6 months
Secondary outcomes:
measure: Correlation of route of nutrition with outcomes
timeFrame: up to a maximum of 6 months
measure: Correlation of timing of start of nutrition with outcomes
timeFrame: up to a maximum of 6 months
measure: Correlation of adequacy of nutrition with outcomes
timeFrame: up to a maximum of 6 months
measure: Correlation of patient generated assessments with outcomes
timeFrame: Baseline, 2, 4 and 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Camperdown
country: Australia
facility: Chris O Brien Lifehouse & Royal Prince Alfred Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Calgary
country: Canada
facility: University of Alberta
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Rome
country: Italy
facility: Sapienza University
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: MB
Study officials:
affiliation: University of Alberta
name: Leah Gramlich, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
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