Clinical trial NCT02093312: Meals on Wheels, the Effect of a Home Food-delivery Service for Cancer Patients
Official title: Meals on Wheels, a Randomized Controlled Study on the Effect of a Home Food-delivery Service for Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Ambulant
Malnourished
Keywords: Cancer
Food-delivery
Nutritional Intervention
Quality of life
Outpatients
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life
timeFrame: 6 weeks (change from baseline)
measure: Quality of Life
timeFrame: 12 weeks (change from baseline)
Secondary outcomes:
measure: Hand grip strength
timeFrame: 6, and 12 weeks (changes from baseline)
measure: 30-second chair-stand test
timeFrame: 6, and 12 weeks (changes from baseline)
measure: Body Weight
timeFrame: 6, and 12 weeks (changes from baseline)
measure: Depression Scale
timeFrame: 6, and 12 weeks (changes from baseline)
measure: Total energy- and protein intake per day
timeFrame: 6, and 12 weeks (changes from baseline)
measure: Re-admissions with total length of stay (LOS)
timeFrame: 12 weeks, and 6 months
measure: Mortality
timeFrame: 12 weeks, and 6 months
measure: WHO Performance status
timeFrame: 6, and 12 weeks
measure: Functional-score
timeFrame: 6 and 12 weeks
measure: Symptom-score
timeFrame: 6 and 12 weeks (changes from baseline)
Other outcomes:
measure: Compliance
timeFrame: 1, 6, and 12 weeks
measure: Evaluation
timeFrame: 12 weeks
measure: Effect of social status on total energy- and protein intake
timeFrame: Baseline
measure: Correlation between compliance (intervention group) and Quality of life
timeFrame: 12 weeks
measure: Correlation between total energy- and protein intake (all participants) and Quality of life
timeFrame: 12 weeks
measure: Correlation between compliance (intervention group) and Body weight
timeFrame: 12 weeks
measure: Correlation between compliance (intervention group) and Hand grib strength
timeFrame: 12 weeks
measure: Correlation between compliance (intervention group) and 30-second chair-stand test
timeFrame: 12 weeks
measure: Correlation between compliance (intervention group) and Depression score
timeFrame: 12 weeks
measure: Correlation between compliance (intervention group) and Total energy- and protein intake
timeFrame: 12 weeks
measure: Correlation between compliance (intervention group) and WHO performance status
timeFrame: 12 weeks
measure: Correlation between total energy- and protein intake (all participants) and Hand grip strength
timeFrame: 12 weeks
measure: Correlation between total energy- and protein intake (all participants) and Body weight
timeFrame: 12 weeks
measure: Correlation between total energy- and protein intake (all participants) and 30 second chair-stand test
timeFrame: 12 weeks
measure: Correlation between total energy- and protein intake (all participants) and Depression scale
timeFrame: 12 weeks
measure: Correlation between total energy- and protein intake (all participants) and WHO performance status
timeFrame: 12 weeks
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hsopital
Study officials:
affiliation: University of Copenhagen
name: Arne V Astrup, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Eva Leedo, Cand Scient
role: STUDY_DIRECTOR
References:
citation: 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.