Cancer, Malnutrition
Conditions
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.
Interventions
OTHERFoodforCare at home
Five small protein rich meals that will be delivered twice a week for 3 weeks.
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and overall health status | 3.5 months | EORTC-Quality of Life-C30 questionnaire filled in before chemotherapy, two times during chemotherapy and after chemotherapy. This questionnaire consists of 30 questions and a total score ranging from 0-100 is calculated based on these questions. The higher the score, the higher the quality of life of the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | 3.5 months | Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy. |
| Nutritional status | 3.5 months | Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy. |
| Functional score | 3.5 months | Karnofsky scale performed before chemotherapy, two times during chemotherapy and once after chemotherapy. This status is based on 11 levels and ranges from 0, indicating death, to 100, indicating no complaints or evidence of disease. |
| Quality of life caregiver | 3.5 months | Caregiver Reaction Assessment (CRA) filled in before chemotherapy, two times during chemotherapy and once after chemotherapy. This questionnaire consist of 24 items in five subscales. All items are statements with a 5-point Likert scale (completely disagree-completely agree). All subscale scores are the average of the item scores, ranging from 1 to 5. There is no total score. |
| Nutritional intake | 3.5 months | 2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy. |
| Symptoms | 3 weeks | Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy |
| Patient satisfaction | 1 day | Questionnaire filled in after 3 weeks of receiving meals. This is a self-developed questionnaire which does not have a total score. Each question will be analyzed separately. Questions consist of grading from 0-10 (the higher, the better the outcome) or with a 5-point Likert scale (completely disagree-completely agree). |
| Functional status | 3.5 months | Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy. |
| Medication use | 3 weeks | Diary filled in during 3 weeks between 2 cycles of chemotherapy |
Countries
Netherlands
Outcome results
None listed