Meals on Wheels, the Effect of a Home Food-delivery Service for Cancer Patients

Study Overview
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Brief Summary
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The overall objective of the study is to investigate the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished patients suffering from cancer on various endpoints.

Detailed Description
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Despite the fact that nutritional deterioration has been associated with patients' functional impairment, the effect of individualized nutritional support or counselling to outpatients, focussing on ordinary food, have not yet been thoroughly explored (Ravasco P. et al. 2007). A few studies have investigated the effect of nutritional counselling on quality of life (QoL) in cancer patients after discharge (Ovesen et al. 1993, Persson et al. 2002, Isenring et al. 2004, Ravasco et al. 2005a, Ravasco et al. 2005b). However, there is to our knowledge not conducted any studies examining the effect of home delivered meals on QoL and other endpoints in outpatients suffering from cancer. The overall objective of the study is to measure the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished outpatients diagnosed with lung cancer. The intervention diet will consist of optional protein- and energy-dense main and in-between-meals. There will be 22 different main meals and 13 in-between meals to choose between. The meals are prepared by The Nordic Kitchen of Copenhagen University Hospital Herlev. The offered main meals will consist of a selection of warm dishes taken from the ordinary menu. The in-between meals are a collection of the Delights of Herlev (dishes previously shown to increase dietary intake among in-patients). The food will be delivered to the participants' home 3 times per week, and participants can order one warm dish and ad libitum in-between meals for each day.

Official Title
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Meals on Wheels, a Randomized Controlled Study on the Effect of a Home Food-delivery Service for Cancer Patients

Conditions
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Lung Cancer, Ambulant, Malnourished

Intervention / Treatment
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* Dietary Supplement: Home food-delivery service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a nutritional risk score ≥ 3 according to NRS-2002 (Kondrup J. et al. 2003) Be diagnosed with lung cancer Have a life expectancy > 12 weeks Not plan to loose weight or go on a diet Not plan to go on vacation for > 2 weeks during the study period Live at their own home Live ≤ 25 km from the hospital Be able to read, write and understand Danish Exclusion Criteria: Receives food from a food-delivery service Have food allergies or intolerance Exclusively receives enteral or parenteral nutrition Suffers from cognitive impairment e.g. dementia Is terminal
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group is not offered any home food-delivery service, but continues with their habitual diet | |
| Experimental: Intervention group<br>The intervention group is offered home food-delivery service | Dietary Supplement: Home food-delivery service<br>* A home food-delivery service is offered the intervention group of cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | To assess the Global QoL, a questionnaire from the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-30, version 3, will be used. This is a validated, cancer-specific questionnaire with a total of 30 questions, looking back at the past week. The scoring of QoL is based on 2 specific questions with response options ranging from 1-7 which indicate very bad to very good. A Danish version of the questionnaire will be used. | 6 weeks (change from baseline) | 
| Quality of Life | To assess the Global QoL, a questionnaire from the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-30, version 3, will be used. This is a validated, cancer-specific questionnaire with a total of 30 questions, looking back at the past week. The scoring of QoL is based on 2 specific questions with response options ranging from 1-7 which indicate very bad to very good. A Danish version of the questionnaire will be used. | 12 weeks (change from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength | Hand grip strength (in kg) will be measured with a Hydraulic Hand Dynamometer. Participants will be seated with forearms rested on the arms of the chair. They are asked to perform three maximum force trials with their dominant hand and using the second handle position. The test will be repeated within 30 seconds, and the maximum grip score from the three measured values will be used. | 6, and 12 weeks (changes from baseline) | 
| 30-second chair-stand test | The 30-second-chair-stand test consist of manually counting the number of sit-stand-sit cycles completed during the 30 seconds of the test. A standard chair (with a seat height of 40cm) with or without a backrest but with armrests will be used. Initially, subject will be seated on the chair with their back in an upright position. They will be instructed to rise after the 1, 2, 3, go command at their own preferred speed with their arms folded across their chest. If the participant is only able to perform the test by using armrest, the test will be recorded as modified. | 6, and 12 weeks (changes from baseline) | 
| Body Weight | Body weight will be measured to the nearest 0.1 kg following standard procedures (i.e. without shoes, minimal clothing). | 6, and 12 weeks (changes from baseline) | 
| Depression Scale | The Center for Epidemiological Studies Depression scale (CES-D) is a short self-report scale designed to measure depressive symptoms (Hann D. et al. 1999). The questionnaire contains 20 items, divided in four domains: Somatic Retarded Activity (7 items), Depressed Affect (5 items), Positive Affect (4 items), and Interpersonal Affect (2 items), and 2 single items that complete the total score. The total score ranges from 0 to 60; a score of ≥16 indicates a depressed symptomatology. The CES-D has been validated in several samples of cancer patients, and it is often administered to inpatients with cancer (Vodermaier A. et al. 2009). A Danish version of the questionnaire will be used. | 6, and 12 weeks (changes from baseline) | 
| Total energy- and protein intake per day | Dietary intake will be assessed by a dietary interview covering patient's dietary intake over the past week. On basis of the dietary interview the total energy and protein intake per day is estimated. A food database with energy- and protein content of various foods is used for the estimation. | 6, and 12 weeks (changes from baseline) | 
| Re-admissions with total length of stay (LOS) | Data on re-admissions to the hospital and LOS will be collected from all participants medical charts (hospital medical system OPUS/GS). | 12 weeks, and 6 months | 
| Mortality | Data on mortality will be collected from all participants' medical charts (hospital medical system OPUS/GS). | 12 weeks, and 6 months | 
| WHO Performance status |  | 6, and 12 weeks | 
| Functional-score | Using EORTC-QLQ-30 version 3 - looking back at the past week. Out of the 30 questions the functional score is based on 15 specific questions with 4 response options indicating either: not at all, a little, some or a lot. Involves questions related to physical-, role-, emotional-, cognitive- and social functioning. | 6 and 12 weeks | 
| Symptom-score | Using EORTC-QLQ-30 version 3 - looking back at the past week. Out of the 30 questions the symptom score is based on 13 specific questions with 4 response options indicating either: not at all, a little, some or a lot. | 6 and 12 weeks (changes from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Food-delivery, Nutritional Intervention, Quality of life, Outpatients