The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy
2020年10月8日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
148
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Gelderland
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Nijmegen、Gelderland、オランダ、6525 GA
- Radboudumc
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
|
介入なし：Usual care group
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of life and overall health status
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Nutritional intake
時間枠：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
時間枠：3.5 months
|
Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
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3.5 months
|
|
Nutritional status
時間枠：3.5 months
|
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
時間枠：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.
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3.5 months
|
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Quality of life caregiver
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Manon van den Berg, PhD、Radboud University Medical Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年11月17日
一次修了 (実際)
2020年5月22日
研究の完了 (実際)
2020年5月22日
試験登録日
最初に提出
2017年11月23日
QC基準を満たした最初の提出物
2017年12月18日
最初の投稿 (実際)
2017年12月22日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月9日
QC基準を満たした最後の更新が送信されました
2020年10月8日
最終確認日
2019年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
癌の臨床試験
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FoodforCare at homeの臨床試験
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Nordsjaellands HospitalUniversity of Southern Denmark; Innovation Fund Denmark完了
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KDH Research & Communication完了
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AZ Sint-Jan AV完了
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Centre Hospitalier Régional Metz-Thionville完了
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University of North Carolina, Chapel HillNational Institute of Nursing Research (NINR)募集