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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02829489




Registration number
NCT02829489
Ethics application status
Date submitted
7/07/2016
Date registered
12/07/2016

Titles & IDs
Public title
International Nutrition Audit in FORegut TuMors
Scientific title
International Audit of Nutrition Care in Patients With FORegut TuMors
Secondary ID [1] 0 0
11111
Universal Trial Number (UTN)
Trial acronym
INFORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Esophageal Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Delivery of nutrition intervention
Timepoint [1] 0 0
up to a maximum of 6 months
Secondary outcome [1] 0 0
Correlation of route of nutrition with outcomes
Timepoint [1] 0 0
up to a maximum of 6 months
Secondary outcome [2] 0 0
Correlation of timing of start of nutrition with outcomes
Timepoint [2] 0 0
up to a maximum of 6 months
Secondary outcome [3] 0 0
Correlation of adequacy of nutrition with outcomes
Timepoint [3] 0 0
up to a maximum of 6 months
Secondary outcome [4] 0 0
Correlation of patient generated assessments with outcomes
Timepoint [4] 0 0
Baseline, 2, 4 and 6 months

Eligibility
Key inclusion criteria
1. Patients with Head and Neck or Esophageal Cancer and
2. At least 18 yrs age.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/10/2019
Sample size
Target
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Chris O Brien Lifehouse & Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Italy
State/province [3] 0 0
Rome
Country [4] 0 0
Netherlands
State/province [4] 0 0
MB

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Fresenius Kabi
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Nutricia Advanced
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Baxter Healthcare Corporation
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leah Gramlich, MD, FRCP
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Clinical study report (CSR)
When will data be available (start and end dates)?
December 2018
Available to whom?
In accordance with the Data Sharing Agreements and contracts with each researcher
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02829489