Clinical trial NCT03382171: The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy
Official title: The Impact of FoodforCare at Home on Quality of Life of Cancer Patients Undergoing Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Malnutrition
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer patients receiving treatment such as chemotherapy experience a variety of symptoms that interfere with their appetite and their ability to eat and enjoy meals. Therefore, adapting meals in a way that responds to these symptoms might be a good strategy to improve patient satisfaction, nutritional status and hence, quality of life. In this vein, the investigators hypothesize that meals from FoodforCare at Home will contribute to the quality of life of cancer patients undergoing chemotherapy when compared to usual care.

Detailed description: Cancer patients receiving treatment such as chemotherapy experience a variety of symptoms that interfere with their appetite and their ability to eat and enjoy meals. Several studies suggest that nutritional intake increases when the patient is satisfied about the quality of the meals. Therefore, adapting meals in a way that responds to these symptoms might be a good strategy to improve patient satisfaction, nutritional status and hence, quality of life. In this vein, the investigators hypothesize that meals from FoodforCare at Home will contribute to the quality of life of cancer patients undergoing chemotherapy when compared to usual care. Also, the investigators expect that this strategy will have a positive effect on patient satisfaction, other nutrition-related issues, including nausea and vomiting, on nutritional intake per se and hence, on the nutritional status. Additional benefits might include reduced use of medication, especially anti-emetics.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* diagnosed with cancer
* receiving chemotherapy according to a minimum schedule of every 2 weeks
* living within a 40 km radius around the Radboud University Nijmegen Medical Centre
* written informed consent

Exclusion Criteria:

* renal insufficiency (MDRD-GFR (glomerular filtration rate) \< 60ml/min and/or proteinuria)\*
* dementia or any other condition which makes it impossible to fill out questionnaires correctly
* unable to understand or speak Dutch
* depending on artificial nutrition in the form of Oral Nutritional Supplements, tube feeding or total parenteral nutrition
* swallowing or passage problems

  * proteinuria is defined in case of a protein creatinine ratio \> 0.5g/10mmol or an albuminuria \> 300mg/day. This is checked by default before the start of chemotherapy by the treating physician to decide whether or not the patient is eligible for receiving chemotherapy.

Primary outcomes:
measure: Quality of life and overall health status
timeFrame: 3.5 months
Secondary outcomes:
measure: Nutritional intake
timeFrame: 3.5 months
measure: Muscle strength
timeFrame: 3.5 months
measure: Nutritional status
timeFrame: 3.5 months
measure: Functional score
timeFrame: 3.5 months
measure: Quality of life caregiver
timeFrame: 3.5 months
measure: Medication use
timeFrame: 3 weeks
measure: Symptoms
timeFrame: 3 weeks
measure: Patient satisfaction
timeFrame: 1 day
measure: Functional status
timeFrame: 3.5 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Manon van den Berg, PhD
role: STUDY_CHAIR
References:
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citation: Leedo E, Gade J, Granov S, Mellemgaard A, Klausen TW, Rask K, Astrup A. The Effect of a Home Delivery Meal Service of Energy- and Protein-Rich Meals on Quality of Life in Malnourished Outpatients Suffering from Lung Cancer: A Randomized Controlled Trial. Nutr Cancer. 2017 Apr;69(3):444-453. doi: 10.1080/01635581.2017.1283421. Epub 2017 Feb 17.
citation: IJmker-Hemink V, Lize N, Beijer S, Raijmakers N, Wanten G, van den Berg M. Lessons learned from a randomized controlled trial on a home delivered meal service in advanced cancer patients undergoing chemotherapy: a pilot study. BMC Nutr. 2021 Feb 16;7(1):4. doi: 10.1186/s40795-021-00407-5.