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

NCT ID: NCT03382171

Last Updated: 2020-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2020-05-22

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.

Conditions

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Cancer Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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FoodforCare group

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.

Group Type EXPERIMENTAL

FoodforCare at home

Intervention Type OTHER

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

Usual care group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FoodforCare at home

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manon van den Berg, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

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Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 25664980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17509812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26106985 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27589258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17368656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28287324 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33588932 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-3044

Identifier Type: -

Identifier Source: org_study_id

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