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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	P05.0473L, NL974 (NTR1001)
Sponsor	Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)
Funder	Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)

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

Medical Centre Alkmaar
Hospital Pharmacy
P.O. Box 501
Alkmaar
1800 AM
Netherlands

Phone	+31 (0)72 548 3591
Email	h.j.doodeman@mca.nl

Study information

Primary study design	Observational
Study design	Multicentre, observational, outcomes research study
Secondary study design	Cohort study
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(s)	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
Key secondary outcome measure(s)	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?
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.