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Head and Neck CancerINFORMNCT02829489

International Nutrition Audit in FORegut TuMors

An observational study of Head and Neck Cancer and Esophageal Cancer, run by University of Alberta at 7 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Head and Neck Cancer, Esophageal Cancer
How many people
170 participants
Where
7 sitesin 5 countries
Study dates
26 Jul 2016to 15 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults with head and/or neck cancer or esophageal cancer

Who may be able to join

  • Patients with Head and Neck or Esophageal Cancer and
  • At least 18 yrs age.

Who cannot join

  • At the time of diagnosis of cancer, if there is no treatment plan due to patient's imminent death OR
  • At the time of diagnosis of cancer, patient's Eastern Cooperative Oncology Score (ECOG) score is ≥ 4

Trial locations and contacts

7 sites in 5 countries.

7 sites in 5 countries

Australia2 sites

  • Chris O Brien Lifehouse & Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

Other trials in Australia

Canada2 sites

  • University of Alberta

    Calgary, Alberta, T2P3B6

  • University of Alberta

    Edmonton, Alberta, T5H 3V9

Other trials in Canada

United States1 site

  • University of California, Davis Medical Center

    Sacramento, California, 95817

Other trials in United States

Italy1 site

  • Sapienza University

    Rome

Other trials in Italy

Netherlands1 site

  • VU University Medical Center

    Amsterdam, MB, 1007

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Keywords
nutrition, foregut tumors, patient related outcomes, audit
Medical subject headings
Head and Neck Neoplasms, Esophageal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delivery of nutrition intervention

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

    Measured: up to a maximum of 6 months

Secondary outcomes (4)

  1. Correlation of route of nutrition with outcomes

    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

    Measured: up to a maximum of 6 months

  2. Correlation of timing of start of nutrition with outcomes

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

    Measured: up to a maximum of 6 months

  3. Correlation of adequacy of nutrition with outcomes

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

    Measured: up to a maximum of 6 months

  4. Correlation of patient generated assessments with outcomes

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

    Measured: Baseline, 2, 4 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2016 (estimated)
  2. Study start26 Jul 2016
  3. Primary completion15 Oct 2019
  4. Study completion15 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02829489
Sponsor's protocol ID
11111
Acronym
INFORM
Status last verified
Nov 2019
First submitted
7 Jul 2016
Last updated
5 Nov 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • Lees J. Incidence of weight loss in head and neck cancer patients on commencing radiotherapy treatment at a regional oncology centre. Eur J Cancer Care (Engl). 1999 Sep;8(3):133-6. doi: 10.1046/j.1365-2354.1999.00156.x.

    PubMed 10763643

  • Hammerlid E, Wirblad B, Sandin C, Mercke C, Edstrom S, Kaasa S, Sullivan M, Westin T. Malnutrition and food intake in relation to quality of life in head and neck cancer patients. Head Neck. 1998 Sep;20(6):540-8. doi: 10.1002/(sici)1097-0347(199809)20:63.0.co;2-j.

    PubMed 9702542

  • Van Cutsem E, Arends J. The causes and consequences of cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S51-63. doi: 10.1016/j.ejon.2005.09.007.

    PubMed 16437758

  • Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9. doi: 10.1016/s0261-5614(02)00215-7.

    PubMed 12765661

  • Rabinovitch R, Grant B, Berkey BA, Raben D, Ang KK, Fu KK, Cooper JS; Radiation Therapy Oncology Group. Impact of nutrition support on treatment outcome in patients with locally advanced head and neck squamous cell cancer treated with definitive radiotherapy: a secondary analysis of RTOG trial 90-03. Head Neck. 2006 Apr;28(4):287-96. doi: 10.1002/hed.20335.

    PubMed 16287132

  • Arends J, Bodoky G, Bozzetti F, Fearon K, Muscaritoli M, Selga G, van Bokhorst-de van der Schueren MA, von Meyenfeldt M; DGEM (German Society for Nutritional Medicine); Zurcher G, Fietkau R, Aulbert E, Frick B, Holm M, Kneba M, Mestrom HJ, Zander A; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Non-surgical oncology. Clin Nutr. 2006 Apr;25(2):245-59. doi: 10.1016/j.clnu.2006.01.020. Epub 2006 May 12.

    PubMed 16697500

  • Martin L, de van der Schueren MA, Blauwhoff-Buskermolen S, Baracos V, Gramlich L. Identifying the Barriers and Enablers to Nutrition Care in Head and Neck and Esophageal Cancers: An International Qualitative Study. JPEN J Parenter Enteral Nutr. 2016 Mar;40(3):355-66. doi: 10.1177/0148607114552847. Epub 2014 Oct 6.

    PubMed 25288589

  • Rose-Ped AM, Bellm LA, Epstein JB, Trotti A, Gwede C, Fuchs HJ. Complications of radiation therapy for head and neck cancers. The patient's perspective. Cancer Nurs. 2002 Dec;25(6):461-7; quiz 468-9. doi: 10.1097/00002820-200212000-00010.

    PubMed 12464838

  • Howell D, Molloy S, Wilkinson K, Green E, Orchard K, Wang K, Liberty J. Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann Oncol. 2015 Sep;26(9):1846-1858. doi: 10.1093/annonc/mdv181. Epub 2015 Apr 17.

    PubMed 25888610

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Cancer and Esophageal Cancer, run by University of Alberta at 7 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia, Canada, United States, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delivery of nutrition intervention (time frame: up to a maximum of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02829489, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.

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