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

Primary Purpose

Cancer, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FoodforCare at home
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radboudumc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FoodforCare group

Usual care group

Arm Description

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.

The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Nutritional intake
2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy.
Muscle strength
Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
Nutritional status
Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
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.
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.
Medication use
Diary filled in during 3 weeks between 2 cycles of chemotherapy
Symptoms
Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy
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).
Functional status
Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.

Full Information

First Posted
November 23, 2017
Last Updated
October 8, 2020
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03382171
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
May 22, 2020 (Actual)
Study Completion Date
May 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Malnutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FoodforCare group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.
Intervention Type
Other
Intervention Name(s)
FoodforCare at home
Intervention Description
Five small protein rich meals that will be delivered twice a week for 3 weeks.
Primary Outcome Measure Information:
Title
Quality of life and overall health status
Description
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.
Time Frame
3.5 months
Secondary Outcome Measure Information:
Title
Nutritional intake
Description
2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy.
Time Frame
3.5 months
Title
Muscle strength
Description
Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
Time Frame
3.5 months
Title
Nutritional status
Description
Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
Time Frame
3.5 months
Title
Functional score
Description
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.
Time Frame
3.5 months
Title
Quality of life caregiver
Description
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.
Time Frame
3.5 months
Title
Medication use
Description
Diary filled in during 3 weeks between 2 cycles of chemotherapy
Time Frame
3 weeks
Title
Symptoms
Description
Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy
Time Frame
3 weeks
Title
Patient satisfaction
Description
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).
Time Frame
1 day
Title
Functional status
Description
Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
Time Frame
3.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manon van den Berg, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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25664980
Citation
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Results Reference
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Citation
Campbell AD, Godfryd A, Buys DR, Locher JL. Does Participation in Home-Delivered Meals Programs Improve Outcomes for Older Adults? Results of a Systematic Review. J Nutr Gerontol Geriatr. 2015;34(2):124-67. doi: 10.1080/21551197.2015.1038463.
Results Reference
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Results Reference
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Marin Caro MM, Laviano A, Pichard C. Nutritional intervention and quality of life in adult oncology patients. Clin Nutr. 2007 Jun;26(3):289-301. doi: 10.1016/j.clnu.2007.01.005. Epub 2007 Mar 21.
Results Reference
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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.
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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.
Results Reference
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The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy

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