The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy
8. oktober 2020 oppdatert av: Radboud University Medical Center
The Impact of FoodforCare at Home on Quality of Life of Cancer Patients Undergoing 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
148
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Gelderland
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Nijmegen, Gelderland, Nederland, 6525 GA
- Radboudumc
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Five small protein rich meals that will be delivered twice a week for 3 weeks.
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Ingen inngripen: Usual care group
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of life and overall health status
Tidsramme: 3.5 months
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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.
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3.5 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Nutritional intake
Tidsramme: 3.5 months
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2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy.
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3.5 months
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Muscle strength
Tidsramme: 3.5 months
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Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
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3.5 months
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Nutritional status
Tidsramme: 3.5 months
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Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
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3.5 months
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Functional score
Tidsramme: 3.5 months
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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.
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3.5 months
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Quality of life caregiver
Tidsramme: 3.5 months
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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.
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3.5 months
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Medication use
Tidsramme: 3 weeks
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Diary filled in during 3 weeks between 2 cycles of chemotherapy
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3 weeks
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Symptoms
Tidsramme: 3 weeks
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Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy
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3 weeks
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Patient satisfaction
Tidsramme: 1 day
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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).
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1 day
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Functional status
Tidsramme: 3.5 months
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Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
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3.5 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Manon van den Berg, PhD, Radboud University Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. november 2017
Primær fullføring (Faktiske)
22. mai 2020
Studiet fullført (Faktiske)
22. mai 2020
Datoer for studieregistrering
Først innsendt
23. november 2017
Først innsendt som oppfylte QC-kriteriene
18. desember 2017
Først lagt ut (Faktiske)
22. desember 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. oktober 2020
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2016-3044
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