Pain in Cancer Patients.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR2739
• Date of registration: 01/02/2011
• Primary sponsor: University Medical Center St. Radboud
• Public title: Pain in Cancer Patients.
• Scientific title: Implementing the Dutch guideline "Pain in Cancer Patients". - Pijnsein
• Date of first enrolment: 15/12/2010
• Target sample size: 210
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2739
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Nienke Boveldt, te

• Name: Yvonne Engels

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Cancer, Pain

Intervention(s)

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.



Control:

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(s)

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(s)

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.

Secondary ID(s)

2011/020

Source(s) of Monetary Support

Bergh in het zadel