Effects of a pain consult and patient education and monitoring: a prospective study in oncology patients

ISRCTN	ISRCTN68236655
DOI	https://doi.org/10.1186/ISRCTN68236655
Protocol serial number	NTR613; EMC 2005 - 257
Sponsor	Erasmus Medical Center (Netherlands)
Funder	Erasmus Medical Center (Netherlands)

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

Dr W.H. Oldenmenger
Scientific

Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone	+31 (0)10 4391439
Email	w.h.oldenmenger@erasmusmc.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	It is hypothesised that a pain consult at the specialized pain clinic in combination with Patient Education Program is more effective in reducing average pain intensity compared to a pain consult alone. A pain consult at the specialized pain clinic is more effective in reducing average pain intensity compared to standard care.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Cancer pain
Intervention	1. Standard care 2. Second opinion pain consult at the specialist pain clinic 3. Second opinion pain consult combined with Pain Education Program and monitoring by nurse specialists
Intervention type	Other
Primary outcome measure(s)	Average pain reduction measured by numeric rating scale during the study period.
Key secondary outcome measure(s)	Effect of the interventions after 2, 4 and 8 weeks on: 1. Adherence to ATC analgesics 2. Worst pain reduction 3. Average pain reduction 4. Present pain reduction 5. Proportion of patients with clinically relevant pain reduction 6. Pain interference 7. Quality of life 8. Reduction of side effects 9. Adequacy of pain treatment 10. Pain knowledge
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	165
Key inclusion criteria	1. Cancer-related pain or cancer treatment related pain for at least two weeks 2. Nociceptive pain 3. Average pain intensity score of 4 or more 4. Accessibility by telephone 5. A life expectancy of at least three months 6. Informed consent
Key exclusion criteria	1. Neuropathic pain 2. Residing in nursing home or retirement home 3. Pain not treated with oral medication 4. Radiotherapy in the past two weeks
Date of first enrolment	01/02/2006
Date of final enrolment	31/12/2007

Erasmus Medical Center

Rotterdam
3008 AE
Netherlands

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