The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy
8 octobre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
148
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Gelderland
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Nijmegen, Gelderland, Pays-Bas, 6525 GA
- Radboudumc
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Five small protein rich meals that will be delivered twice a week for 3 weeks.
|
|
Aucune intervention: Usual care group
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of life and overall health status
Délai: 3.5 months
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nutritional intake
Délai: 3.5 months
|
2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy.
|
3.5 months
|
|
Muscle strength
Délai: 3.5 months
|
Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
|
3.5 months
|
|
Nutritional status
Délai: 3.5 months
|
Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
|
3.5 months
|
|
Functional score
Délai: 3.5 months
|
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
|
|
Quality of life caregiver
Délai: 3.5 months
|
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
|
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Medication use
Délai: 3 weeks
|
Diary filled in during 3 weeks between 2 cycles of chemotherapy
|
3 weeks
|
|
Symptoms
Délai: 3 weeks
|
Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy
|
3 weeks
|
|
Patient satisfaction
Délai: 1 day
|
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
|
|
Functional status
Délai: 3.5 months
|
Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
|
3.5 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Manon van den Berg, PhD, Radboud University Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 novembre 2017
Achèvement primaire (Réel)
22 mai 2020
Achèvement de l'étude (Réel)
22 mai 2020
Dates d'inscription aux études
Première soumission
23 novembre 2017
Première soumission répondant aux critères de contrôle qualité
18 décembre 2017
Première publication (Réel)
22 décembre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 octobre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 octobre 2020
Dernière vérification
1 avril 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2016-3044
Plan pour les données individuelles des participants (IPD)
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Non
Informations sur les médicaments et les dispositifs, documents d'étude
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Étudie un produit d'appareil réglementé par la FDA américaine
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produit fabriqué et exporté des États-Unis.
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