Condition category
Cancer
Date applied
20/02/2007
Date assigned
20/02/2007
Last edited
28/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17605796
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26013765

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes