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

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: App for diet record (MyFood)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyFood (App for diet record)<br>Use of an App for diet record | Other: App for diet record (MyFood)<br>* 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.<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | weight measurements | During the 17 weeks | 
| Nutrition intake | 24-hour recall interviews | Monthly up to three months | 
| Body composition | Bioelectrical Impedance Analysis (BIA) | Monthly up to three months | 
| 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). | Monthly up to three months | 
| Number of Participants compliant to the intervention | Review of reported use of the MyFood app in the electronic patient record | At 17 weeks | 
| Number of patients with non-elective readmissions | Review of readmissions in the electronic patient record | At 17 weeks |