|- candidate number||9055|
|- NTR Number||NTR2739|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-feb-2011|
|- Secondary IDs||2011/020 METC UMC St Radboud|
|- Public Title||Pain in Cancer Patients.|
|- Scientific Title||Implementing the Dutch guideline "Pain in Cancer Patients".|
|- hypothesis||Publishing a guideline is not enough. An implementation strategy is needed to improve pain reporting, pain measurement and adequate pain therapy. |
|- Healt Condition(s) or Problem(s) studied||Cancer, Pain|
|- Inclusion criteria||Participants:|
Via the hospital boards, professional caregivers, oncologists and nurses involved in cancer care of the six participating hospitals will be invited to take part. Patients who visit the oncology outpatient clinic will be screened for possible inclusion. Patients will be invited to take part by their medical oncologist or research nurse if they experience pain for the first time caused by cancer.
Overall inclusion criteria for patients are:
1. Diagnosed with cancer;
2. Aged 18 years or older;
3. Pain intensity of 3 or more on an numeric rating scale (NRS) for the worst pain experienced in the last 24 hours;
4. Having and being familiar with the use of a mobile phone.
|- Exclusion criteria||1. Dementia and other severe cognitive disorders;|
2. No informed consent;
3. Not Dutch speaking and writing.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-dec-2010|
|- planned closingdate||15-dec-2014|
|- Target number of participants||210|
|- Interventions||Multifaceted intervention:|
1. In-person training in the most important aspects of the guideline (including 2 repeating sessions) (in total three sessions of one hour- few hours) of medical oncologists and nurses at the medical oncology outpatient clinincs;
2. Interactive computer-based training (once) in the most important aspects of the guideline will be offered to general praticitioners;
3. Pateints recieve SMS-alerts once a week to ask for their pain (NRS score). If patients have an NRS score of 5 of higher a nurse will contact the patient and the patient will recieve a personal advice how to reduce his/her pain.
Training will not be offered to medical professionals in the control group and patients with cancer recieve a KWF-leaflet on cancer pain.
|- Primary outcome||1. Percentage of all patients that visit the medical oncology outpatient clinic with adequate pain therapy/medication with the Pain Management Index (PMI);|
2. Mean pain intensity of those cancer patients with pain (NRS).
|- Secondary outcome||1. Percentage of medical records of new patients in the outpatients oncology clinic, in which pain is registered with NRS;|
2. Quality of life of patients with pain (EORTC QLQ-C30);
3. Knowledge of doctors of content of the guideline (questionnaire and Vignette);
4. Prospective descriptive study of pain intensity of the group of patients that will be monitored via sms-alerts and SMS pain reporting;
5. Process evaluation of the intervention study.
|- Timepoints||1. Knowledge questionnaire Vignette medical professionals: At baseline and after 12 months;|
2. Knowledge questionnaire for GPs: At baseline, 6 weeks after web-based training and after 12 months;
3. Patients with cancer measurements: Quality of life, PMI at baseline, after three months. NRS (SMS-alerts) and pain diary once a week for three months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. Nienke Boveldt, te|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Yvonne Engels|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|Bergh in het zadel|
|- Brief summary||Background: |
The prevalence of pain in patients with cancer is high. In 2007, nearly one out of two patients with cancer pain was undertreated. Inadequate pain control still remains an important problem. Therefore, in 2008 a national, evidence-based multidisciplinary guideline "pain in patients with cancer" has been developed. Yet, publishing a guideline is not enough. Implementation of guidelines is needed to improve pain reporting and pain management. This study aims to implement the Dutch guideline pain in patients with cancer. This implementation will improve pain reporting, pain measurement and hence pain control in newly diagnosed patients with cancer in pain. As an innovative tool the interactive voice control is used to improve the pain reporting and to improve the training of medical oncologists, nurses and general practitioners.
A randomised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern part of the Netherlands, with three hospitals in the intervention condition and three in the control condition. Follow-up measurements will be conducted in all hospitals, to study the long-term effect of the intervention. The intervention includes training of professionals (medical oncologists, nurses and general practitioners) and Short Message Service with Interactive Voice Response SMS alert to report pain in patients with cancer. Besides, in both conditions a patient leaflet of the Dutch Cancer Society on cancer pain as well as a pain diary will be used.
|- Main changes (audit trail)|
|- RECORD||1-feb-2011 - 25-sep-2011|