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

NCT03382171 | Completed

• 1 other identifier: 2016-3044
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Nutritional intake

  3.5 months

• Muscle strength

  3.5 months

• Nutritional status

  3.5 months

• Functional score

  3.5 months

• Quality of life caregiver

  3.5 months

Study Arms (2)

FoodforCare group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

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

Interventions

FoodforCare at home OTHER

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

FoodforCare group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 25664980 BACKGROUND

• 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. doi: 10.1016/j.jpainsymman.2006.10.015. Epub 2007 May 23.

  PMID: 17509812 BACKGROUND

• 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.

  PMID: 26106985 BACKGROUND

• 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.

  PMID: 27589258 BACKGROUND

• 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.

  PMID: 17368656 BACKGROUND

• 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.

  PMID: 28287324 BACKGROUND

• 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.

  PMID: 33588932 DERIVED

MeSH Terms

Conditions

Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Manon van den Berg, PhD

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 22, 2017
• Study Start: November 17, 2017
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: October 9, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)