International Nutrition Audit in FORegut TuMors (INFORM)

November 1, 2019 updated by: University of Alberta

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O Brien Lifehouse & Royal Prince Alfred Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • Alberta
      • Calgary, Alberta, Canada, T2P3B6
        • University of Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • University of Alberta
      • Rome, Italy
        • Sapienza University
    • MB
      • Amsterdam, MB, Netherlands, 1007
        • VU University Medical Center
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with head and/or neck cancer or esophageal cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery of nutrition intervention
Time Frame: up to a maximum of 6 months
What is the timing of start of nutrition, adequacy of nutrition and the route of nutrition (oral, enteral and/or parenteral)
up to a maximum of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of route of nutrition with outcomes
Time Frame: up to a maximum of 6 months
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
up to a maximum of 6 months
Correlation of timing of start of nutrition with outcomes
Time Frame: up to a maximum of 6 months
Does the timing of initiation of nutrition intervention correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity
up to a maximum of 6 months
Correlation of adequacy of nutrition with outcomes
Time Frame: up to a maximum of 6 months
Does the adequacy of nutrition intervention correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity
up to a maximum of 6 months
Correlation of patient generated assessments with outcomes
Time Frame: Baseline, 2, 4 and 6 months
Does the PGSGA correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity
Baseline, 2, 4 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Leah Gramlich, MD, FRCP, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2016

Primary Completion (Actual)

October 15, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 11111 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

December 2018

IPD Sharing Access Criteria

In accordance with the Data Sharing Agreements and contracts with each researcher

IPD Sharing Supporting Information Type

  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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