Head and Neck Cancer
Conditions
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.
Interventions
OTHERApp for diet record (MyFood)
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.
Sponsors
Oslo University Hospital
University of South-Eastern Norway
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malnutrition_PGSGA | 18 weeks | Measured by the: 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
| Measure | Time frame | Description |
|---|---|---|
| Weight change | 18 weeks | weight measurements |
| Nutrition intake | 18 weeks | 24-hour recall interviews |
| Body composition | 18 weeks | Bioelectrical Impedance Analysis (BIA) |
| Malnutrition GLIM | 18 weeks | Malnutrition measured by the objective method developed by the Global Leadership Initiative on Malnutrition (GLIM). The GLIM-criteria also categories the participants i three groups: Well-nourished, moderate malnutrition and severe malnutrition. |
| Number of Participants compliant to the intervention | 18 weeks | Review of reported use of the MyFood app in the electronic patient record |
| Number of patients with non-elective readmissions | 18 weeks | Review of readmissions in the electronic patient record |
| Health-related quality of life | 18 weeks | 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). |
Countries
Norway
Outcome results
None listed