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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382171
• Other study ID #: 2016-3044
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: May 22, 2020

Study information

• Verified date: April 2019
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 22, 2020
• Est. primary completion date: May 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Malnutrition

Intervention

Other:
• FoodforCare at home
Five small protein rich meals that will be delivered twice a week for 3 weeks.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. Review. — View Citation

Coa KI, Epstein JB, Ettinger D, Jatoi A, McManus K, Platek ME, Price W, Stewart M, Teknos TN, Moskowitz B. The impact of cancer treatment on the diets and food preferences of patients receiving outpatient treatment. Nutr Cancer. 2015;67(2):339-53. doi: 10.1080/01635581.2015.990577. Epub 2015 Feb 9. — View Citation

Dashti HS, Mogensen KM. Recommending Small, Frequent Meals in the Clinical Care of Adults: A Review of the Evidence and Important Considerations. Nutr Clin Pract. 2017 Jun;32(3):365-377. doi: 10.1177/0884533616662995. Epub 2016 Sep 1. Review. — View 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. — View Citation

Marín Caro MM, Laviano A, Pichard C. Nutritional intervention and quality of life in adult oncology patients. Clin Nutr. 2007 Jun;26(3):289-301. Epub 2007 Mar 21. Review. — View Citation

Teunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manage. 2007 Jul;34(1):94-104. Epub 2007 May 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nutritional intake	2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy.	3.5 months
Secondary	Muscle strength	Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.	3.5 months
Secondary	Nutritional status	Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.	3.5 months
Secondary	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
Secondary	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
Secondary	Medication use	Diary filled in during 3 weeks between 2 cycles of chemotherapy	3 weeks
Secondary	Symptoms	Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy	3 weeks
Secondary	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
Secondary	Functional status	Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.	3.5 months