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Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home (NUTREAT)

Primary Purpose

Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
App for diet record (MyFood)
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Head and neck cancer Older than 18 years Exclusion Criteria: Patients admitted with the classification of malignant tumors (TNM) stage 4 Terminal condition (life expectancy < 6 months) Patients who do not understand the Norwegian language.

Sites / Locations

  • University of Oslo
  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MyFood (App for diet record)

Usual care

Arm Description

Use of an App for diet record

Usual care

Outcomes

Primary Outcome Measures

Malnutrition
Patient-Generated Subjective Global Assessment (PG-SGA). The tool categories participants into: category A (Well-nourished), B (Moderately malnutrition or possible malnutrition), or C (serious malnutrition)

Secondary Outcome Measures

Weight change
weight measurements
Nutrition intake
24-hour recall interviews
Body composition
Bioelectrical Impedance Analysis (BIA)
Health-related quality of life
EuroQol Research Foundation, Netherlands (EQ5D-5L). Assess health in 5 dimensions each of which has three response levels (1: No problems, 2: some problems and 3: extreme problems/unable to do).
Number of Participants compliant to the intervention
Review of reported use of the MyFood app in the electronic patient record
Number of patients with non-elective readmissions
Review of readmissions in the electronic patient record

Full Information

First Posted
June 26, 2023
Last Updated
October 11, 2023
Sponsor
University of Oslo
Collaborators
Oslo University Hospital, University of South-Eastern Norway
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1. Study Identification

Unique Protocol Identification Number
NCT05997329
Brief Title
Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home
Acronym
NUTREAT
Official Title
Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Oslo University Hospital, University of South-Eastern Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with cancer have increased risk of malnutrition due to the disease itself and the treatment regimen they undergo. This is particularly relevant for patients with head and neck cancer (HNC), where 74%-95% are malnourished. HNC is a heterogenous group of cancers, including oral cavity, larynx, pharynx and salivary glands. The present project will study the effectiveness and implementation of remote patient monitoring of nutrition and tailored nutrition support throughout the treatment course in patients with head and neck cancer. The implementation will be evaluated in a randomized controlled trial (RCT), and the aim of the project is to reduce the prevalence of malnutrition and increase the quality of life among patients with HNC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MyFood (App for diet record)
Arm Type
Experimental
Arm Description
Use of an App for diet record
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
App for diet record (MyFood)
Intervention Description
Patients in the intervention group will record their food intake, tube feeding, nutrition-related symptoms and body weight in the MyFood app in at least three consecutive days in advance of follow-up.The patients will thus be able to keep track of their nutrition status. They will also have access to nutrition tips for how to reach requirements if they struggle to eat sufficiently or relief symptoms that can affect food intake.Healthcare staff at the hospital and outpatient clinics will use MyFood to monitor the patient's nutrition and document this information in the electronic patient record. They will also receive decision support tailored to each individual patient, e.g. recommendations for how to use oral nutrition supplements if the patient's intake of energy or protein is too low. Patients who struggle to fulfill their requirements will receive an additional referral to a registered dietitian for nutrition treatment between week 5 and 11.
Primary Outcome Measure Information:
Title
Malnutrition
Description
Patient-Generated Subjective Global Assessment (PG-SGA). The tool categories participants into: category A (Well-nourished), B (Moderately malnutrition or possible malnutrition), or C (serious malnutrition)
Time Frame
17 weeks
Secondary Outcome Measure Information:
Title
Weight change
Description
weight measurements
Time Frame
During the 17 weeks
Title
Nutrition intake
Description
24-hour recall interviews
Time Frame
Monthly up to three months
Title
Body composition
Description
Bioelectrical Impedance Analysis (BIA)
Time Frame
Monthly up to three months
Title
Health-related quality of life
Description
EuroQol Research Foundation, Netherlands (EQ5D-5L). Assess health in 5 dimensions each of which has three response levels (1: No problems, 2: some problems and 3: extreme problems/unable to do).
Time Frame
Monthly up to three months
Title
Number of Participants compliant to the intervention
Description
Review of reported use of the MyFood app in the electronic patient record
Time Frame
At 17 weeks
Title
Number of patients with non-elective readmissions
Description
Review of readmissions in the electronic patient record
Time Frame
At 17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Head and neck cancer Older than 18 years Exclusion Criteria: Patients admitted with the classification of malignant tumors (TNM) stage 4 Terminal condition (life expectancy < 6 months) Patients who do not understand the Norwegian language.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Henriksen, PhD
Phone
+4799003128
Email
christine.henriksen@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Mari Mohn Paulsen, PhD
Facility Information:
Facility Name
University of Oslo
City
Oslo
ZIP/Postal Code
0316
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Henriksen, PhD
Phone
+4799003128
Email
christine.henriksen@medisin.uio.no
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Warmbrodt, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home

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