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AzTrials

Lung CancerRUMLENCT02093312

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

A study testing Home food-delivery service in people with Lung Cancer and Ambulant, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lung Cancer, Ambulant, Malnourished
What is being tested?
Home food-delivery service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteDenmark
Study dates
Mar 2014to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Herlev University Hsopital

    Herlev, 2730

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Home food-delivery service
Keywords
Cancer, Food-delivery, Nutritional Intervention, Quality of life, Outpatients
Medical subject headings
Lung Neoplasms, Malnutrition, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home food-delivery serviceDietary supplement

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

Study groups in NCT02093312
Study groupRoleWhat they receive
Control groupNo interventionThe control group is not offered any home food-delivery service, but continues with their habitual diet
Intervention groupExperimentalThe intervention group is offered home food-delivery service
Receives: Dietary Supplement: Home food-delivery service

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks (change from baseline)

  2. 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.

    Measured: 12 weeks (change from baseline)

Secondary outcomes (10)

  1. 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.

    Measured: 6, and 12 weeks (changes from baseline)

  2. 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".

    Measured: 6, and 12 weeks (changes from baseline)

  3. Body Weight

    Body weight will be measured to the nearest 0.1 kg following standard procedures (i.e. without shoes, minimal clothing).

    Measured: 6, and 12 weeks (changes from baseline)

  4. 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.

    Measured: 6, and 12 weeks (changes from baseline)

  5. 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.

    Measured: 6, and 12 weeks (changes from baseline)

  6. 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).

    Measured: 12 weeks, and 6 months

  7. Mortality

    Data on mortality will be collected from all participants' medical charts (hospital medical system OPUS/GS).

    Measured: 12 weeks, and 6 months

  8. WHO Performance status

    Measured: 6, and 12 weeks

  9. 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.

    Measured: 6 and 12 weeks

  10. 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.

    Measured: 6 and 12 weeks (changes from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionOct 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02093312
Sponsor's protocol ID
EFFECT.A03.2014
Acronym
RUMLE
Status last verified
Dec 2022
First submitted
20 Feb 2014
Last updated
21 Dec 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28287324

Questions about this trial

What is this clinical trial studying?

A study testing Home food-delivery service in people with Lung Cancer and Ambulant, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (time frame: 6 weeks (change from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02093312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.

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