Introduction of a breast cancer care programme in ultra short stay (ambulatory/24 stay setting) in four early adopter centres: implementation and evaluation

ISRCTN	ISRCTN77253391
DOI	https://doi.org/10.1186/ISRCTN77253391
Protocol serial number	945-14-411
Sponsor	University Hospital Maastricht (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development

Submission date: 20/02/2007
Registration date: 20/02/2007
Last edited: 28/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof M F Meyenfeldt
Scientific

University Hospital Maastricht
Departement of Surgery
PO Box 5800
Maastricht
6202 AZ
Netherlands

Phone	+31 (0)43 387 7478
Email	mf.vonmeyenfeldt@ah.unimaas.nl

Study information

Primary study design	Interventional
Study design	Pre-post uncontrolled prospective trial
Secondary study design	Non randomised study
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
Study acronym	MADO
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	Breast cancer
Intervention	A comprehensive care programme for breast cancer surgery in ultra short stay in four early adopter hospitals.
Intervention type	Other
Primary outcome measure(s)	Percent patients in ultra short stay: 1. Percent patients treated according to protocol 2. Cost-effectiveness of the care programme and implementation programme
Key secondary outcome measure(s)	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
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	400
Key inclusion criteria	Breast cancer patients of all ages undergoing all types of surgical interventions for breast cancer.
Key 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.
Date of first enrolment	01/12/2004
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Hospital Maastricht

Maastricht
6202 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/05/2015		Yes	No
Protocol article	protocol	02/07/2007		Yes	No