The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy
8 de octubre de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
148
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Gelderland
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Nijmegen, Gelderland, Países Bajos, 6525 GA
- Radboudumc
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: Usual care group
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of life and overall health status
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nutritional intake
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Manon van den Berg, PhD, Radboud University Medical Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de noviembre de 2017
Finalización primaria (Actual)
22 de mayo de 2020
Finalización del estudio (Actual)
22 de mayo de 2020
Fechas de registro del estudio
Enviado por primera vez
23 de noviembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
18 de diciembre de 2017
Publicado por primera vez (Actual)
22 de diciembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
8 de octubre de 2020
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016-3044
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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Ensayos clínicos sobre FoodforCare at home
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Datar Cancer Genetics LimitedNational University of Singapore; Test At Home Pte. LtdAún no reclutando
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University of MichiganTerminadoSíntomas de comportamiento | Desordenes mentales | Desorden depresivo | Depresión | Trastornos del estado de ánimoEstados Unidos
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Attralus, Inc.Terminado
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Centre Hospitalier Régional Metz-ThionvilleTerminadoCatarata | Implante de lente intraocularFrancia
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University Health Network, TorontoSunnybrook Health Sciences Centre; University of TorontoTerminado
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University of MichiganTerminadoSíntomas de comportamiento | Desorden depresivo | Depresión | Trastornos del estado de ánimo | Trastorno mentalEstados Unidos
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The University of Hong KongInscripción por invitación