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OpenTrials
Completed

NCT Number: NCT03382171

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FoodforCare at home

Other

Five small protein rich meals that will be delivered twice a week for 3 weeks.

Primary outcomes

  1. Quality of life and overall health status

    Time frame: 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 outcomes

  1. Nutritional intake

    Time frame: 3.5 months

    2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy.

  2. Muscle strength

    Time frame: 3.5 months

    Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.

  3. Nutritional status

    Time frame: 3.5 months

    Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.

  4. Functional score

    Time frame: 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.

  5. Quality of life caregiver

    Time frame: 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.

  6. Medication use

    Time frame: 3 weeks

    Diary filled in during 3 weeks between 2 cycles of chemotherapy

  7. Symptoms

    Time frame: 3 weeks

    Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy

  8. Patient satisfaction

    Time frame: 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).

  9. Functional status

    Time frame: 3.5 months

    Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2017
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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