The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of FoodforCare at Home on Quality of Life of Cancer Patients Undergoing Chemotherapy.

Conditions
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Cancer, Malnutrition

Intervention / Treatment
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* Other: FoodforCare at home


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FoodforCare group<br>The intervention group will receive meals from FoodforCare at Home. The FoodforCare at Home concept consists of five to six small protein and energy enriched meals that will be delivered twice a week. After an individual intake, the composition of the dishes will be tailored to the needs of the patient in terms of composition, diet, taste, flavor and portion size. Besides the meals, patients in the intervention group will also receive an information leaflet about the importance of protein during treatment and how to reach their protein requirements. | Other: FoodforCare at home<br>* Five small protein rich meals that will be delivered twice a week for 3 weeks.<br>|
| No Intervention: Usual care group<br>The control group will continue their usual diet for 3 weeks and have no restrictions to their diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and overall health status | 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. | 3.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional intake | 2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy. | 3.5 months | 
| Muscle strength | Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy. | 3.5 months | 
| Nutritional status | Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy. | 3.5 months | 
| Functional score | 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. | 3.5 months | 
| Quality of life caregiver | 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. | 3.5 months | 
| Medication use | Diary filled in during 3 weeks between 2 cycles of chemotherapy | 3 weeks | 
| Symptoms | Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy | 3 weeks | 
| Patient satisfaction | 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). | 1 day | 
| Functional status | Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy. | 3.5 months |