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 |
| Secondary identifying numbers | 945-14-411 |
- 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
Scientific
University Hospital Maastricht
Departement of Surgery
PO Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 387 7478 |
|---|---|
| mf.vonmeyenfeldt@ah.unimaas.nl |
Study information
| Study design | Pre-post uncontrolled prospective trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/12/2004 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
6202 AZ
Netherlands
Sponsor information
University Hospital Maastricht (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
PO Box 5800
Maastricht
6202 AZ
Netherlands
| Website | http://www.unimaas.nl/default.asp?template=home.htm&fac=@fac@&nid=@nid@&id=niks&taal=en |
|---|---|
"ROR" |
https://ror.org/02d9ce178 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/07/2007 | Yes | No | |
| Results article | results | 27/05/2015 | Yes | No |
