A multicentre outcome research in daily clinical practice concerning the prevention of acute and delayed nausea and vomiting after chemotherapy: an outcome research
| ISRCTN | ISRCTN55375237 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55375237 |
| Secondary identifying numbers | P05.0473L, NL974 (NTR1001) |
- Submission date
- 16/07/2007
- Registration date
- 16/07/2007
- Last edited
- 27/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H.J. Doodeman
Scientific
Scientific
Medical Centre Alkmaar
Hospital Pharmacy
P.O. Box 501
Alkmaar
1800 AM
Netherlands
| Phone | +31 (0)72 548 3591 |
|---|---|
| h.j.doodeman@mca.nl |
Study information
| Study design | Multicentre, observational, outcomes research study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | A multicentre outcome research in daily clinical practice concerning the prevention of acute and delayed nausea and vomiting after chemotherapy: an outcome research |
| Study objectives | 1. Adherence to guidelines/protocols is unsatisfactory 2. No regimen is superior in the proportion of patients with minimal or no impact of emesis on daily living as measured using the Functional Living Index-Emesis questionnaire |
| Ethics approval(s) | Approval received from the local medical ethics committee (Medisch Ethische Toetsingscommissie Noord-Holland [METC Noord-Holland]) on the 12th April 2005 (ref: M05-011). |
| Health condition(s) or problem(s) studied | Quality of life and chemotherapy induced nausea and vomiting |
| Intervention | This study uses self reported sides effects including nausea and vomiting by means of a patient diary which also includes a quality of life assessment. |
| Intervention type | Other |
| Primary outcome measure | 1. To make an inventory on the anti-emetic policy in several peripheral hospitals 2. To make an inventory on the effectiveness of these anti-emetic policies |
| Secondary outcome measures | 1. What is the difference in anti-emetic policies used in several peripheral hospitals? 2. Do these anti-emetic policies correspond with evidence based guidelines? 3. Is aprepitant used in high emetogenic chemotherapy treatment or moderate emetogenic chemotherapy treatment? 4. What is the incidence of acute and delayed nausea and vomiting in chemotherapy treatment and does this correspond with literature? 5. Can differences in effectiveness be explained by differences in patient characteristics, chemotherapy and/or anti-emetic policy? |
| Overall study start date | 15/04/2005 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 600 |
| Key inclusion criteria | Chemotherapy naive patients receiving chemotherapy. |
| Key exclusion criteria | 1. Life expectancy less than three months 2. Lack of basic proficiency in Dutch 3. Age below 18 4. Pregnancy 5. Psychological illness |
| Date of first enrolment | 15/04/2005 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Medical Centre Alkmaar
Alkmaar
1800 AM
Netherlands
1800 AM
Netherlands
Sponsor information
Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Hospital Pharmacy
Alkmaar
1800 AM
Netherlands
| Website | http://www.mca.nl/webframe/modules/mod_webcontroleur/voorkant.php?id=5 |
|---|---|
"ROR" |
https://ror.org/04vccmr34 |
Funders
Funder type
Hospital/treatment centre
Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)
No information available
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 | Not provided at time of registration |
Editorial Notes
27/10/2021: Proactive update review. No publications found. Search options exhausted.
