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

NCT ID: NCT02093312

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-04-30

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.

Conditions

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Lung Cancer Ambulant Malnourished

Keywords

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Cancer Food-delivery Nutritional Intervention Quality of life Outpatients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

The control group is not offered any home food-delivery service, but continues with their habitual diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

The intervention group is offered home food-delivery service

Group Type EXPERIMENTAL

Home food-delivery service

Intervention Type DIETARY_SUPPLEMENT

A home food-delivery service is offered the intervention group of cancer patients

Interventions

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Home food-delivery service

A home food-delivery service is offered the intervention group of cancer patients

Intervention Type DIETARY_SUPPLEMENT

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Christian Bitz

Head of Reseach

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arne V Astrup, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Eva Leedo, Cand Scient

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

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Herlev University Hsopital

Herlev, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 28287324 (View on PubMed)

Other Identifiers

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EFFECT.A03.2014

Identifier Type: -

Identifier Source: org_study_id