Condition category
Signs and Symptoms
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
10/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr W.H. Oldenmenger

ORCID ID

Contact details

Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391439
w.h.oldenmenger@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR613; EMC 2005 - 257

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Average pain reduction measured by numeric rating scale during the study period.

Secondary outcome measures

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

Overall trial start date

01/02/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

165

Participant 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

Recruitment start date

01/02/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3008 AE
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Erasmus Medical Center (Netherlands)

Alternative name(s)

Erasmus Medical Center, Erasmus MC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes