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Trial Title:
Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home
NCT ID:
NCT05997329
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
App for diet record (MyFood)
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.
Arm group label:
MyFood (App for diet record)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Oslo
Address:
City:
Oslo
Zip:
0316
Country:
Norway
Contact:
Last name:
Christine Henriksen, PhD
Phone:
+4799003128
Email:
christine.henriksen@medisin.uio.no
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Country:
Norway
Contact:
Last name:
Nicole Warmbrodt, MSc
Start date:
November 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of Oslo
Agency class:
Other
Collaborator:
Agency:
Oslo University Hospital
Agency class:
Other
Collaborator:
Agency:
University of South-Eastern Norway
Agency class:
Other
Source:
University of Oslo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05997329
