Contact information
Type
Scientific
Primary contact
Prof M F Meyenfeldt
ORCID ID
Contact details
University Hospital Maastricht
Departement of Surgery
PO Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 387 7478
mf.vonmeyenfeldt@ah.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
945-14-411
Study information
Scientific title
Introduction of a breast cancer care programme in ultra short stay (ambulatory/24 stay setting) in four early adopter centres: implementation and evaluation
Acronym
MADO
Study hypothesis
The aim of the knowledge transfer activities in this project is to inform relevant stakeholders about a set of interventions to support establishing a comprehensive care programme for breast cancer surgery in ultra short stay (the University Hospital Maastricht (UHM) breast cancer care programme).
There is no hypothesis in this implementation study, that is designed to record facilitating and inhibiting factors when an accepted and well functioning care programme is introduced in four early adopter hospitals.
Ethics approval
The study was approved by the medical ethical committees of the initiating hospital (University Hospital Maastricht on the 7th December 2005 [ref: MEC 05-108]) and the other four hospitals:
1. Laurentius Hospital (ref: 05/11 PT/ SK 05/ 331) on the 6th December 2005
2. Orbis Medical Center (ref: 05.190/CS.EH) on the 28th October 2005
3. Leiden University Medical Center (ref: P05.111) on the 17th November 2005
4. St. Elisabeth Hospital (ref: 0536) on the 14th September 2005
Study design
Pre-post uncontrolled prospective trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Breast cancer
Intervention
A comprehensive care programme for breast cancer surgery in ultra short stay in four early adopter hospitals.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Percent patients in ultra short stay:
1. Percent patients treated according to protocol
2. Cost-effectiveness of the care programme and implementation programme
Secondary outcome measures
1. Patient satisfaction
2. Degree of involvement of home care nursing)
Process indicators:
1. Access time to out patient department
2. Time spent in the diagnostic process
3. Access time to the surgical procedure
4. Surgical quality of care (complications, number of re-operations)
5. Patient satisfaction
Overall trial start date
01/12/2004
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Breast cancer patients of all ages undergoing all types of surgical interventions for breast cancer.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
Contraindications are those related to the physiology of the patient, and therefore not age or any of the surgery types employed in the treatment of breast cancer.
Recruitment start date
01/12/2004
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Hospital Maastricht
Maastricht
6202 AZ
Netherlands
Sponsor information
Organisation
University Hospital Maastricht (The Netherlands)
Sponsor details
Department of Surgery
PO Box 5800
Maastricht
6202 AZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
http://www.unimaas.nl/default.asp?template=home.htm&fac=@fac@&nid=@nid@&id=niks&taal=en
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17605796
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26013765
Publication citations
-
Protocol
de Kok M, Frotscher CN, van der Weijden T, Kessels AG, Dirksen CD, van de Velde CJ, Roukema JA, Bell AV, van der Ent FW, von Meyenfeldt MF, Introduction of a breast cancer care programme including ultra short hospital stay in 4 early adopter centres: framework for an implementation study., BMC Cancer, 2007, 7, 117, doi: 10.1186/1471-2407-7-117.
-
Results
Ament SM, de Kok M, van de Velde CJ, Roukema JA, Bell TV, van der Ent FW, van der Weijden T, von Meyenfeldt MF, Dirksen CD, A detailed report of the resource use and costs associated with implementation of a short stay programme for breast cancer surgery, Implement Sci. , 2015 , 10, 1, 78.