Palliation: the Effect of Education on Pain (PEEP)
Rationale: Although radiotherapy is an effective palliative treatment for patients with painful bone metastases with over 70% responders, pain intensity is not always sufficiently controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients show that during weekly follow up, 35% of the patients remain above a pain intensity level of 4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline 'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain control. However, the effect of a nurse-led education of patients undergoing palliative radiotherapy for painful bone metastases has not been investigated yet.
Objective: This project investigates whether nurse-led pain education in addition to standard care results in better control of pain in patients referred for palliative radiotherapy.
Study design: A national multicenter phase 3 study (n=450).
Study population: Patients with painful bone metastases referred for short schedule radiotherapy.
Intervention: Patients will be randomized between standard care or standard care with the Pain Education Program, a nurse-led pain education. The pain Education Program will be provided on the same day the radiotherapeutic treatment will start. The nurse will first assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses will telephone patients at regular intervals during follow-up to monitor their needs.
Main study parameters/endpoints: The primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group. The secondary outcome is improvement of quality of life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pain Education for Patients With Painful Bone Metastases Undergoing Palliative Radiotherapy: Reducing Pain by Increasing Patient's Knowledge and Self-management|
- a decrement of the number of patients whose worst pain intensity remains above 4 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group.
- improvement of quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Pain education
Patients receiving pain education
Behavioral: Pain education
Patients receiving pain education
No Intervention: No Pain education
Control group, patients receiving no pain education
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358539
|Contact: A KL Reyners, MD, PhDfirstname.lastname@example.org|
|Contact: J A Gietema, MD, PhD||+31 50 email@example.com|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9713 GZ|
|Contact: A KL Reyners, MD, PhD +31 50 3616161 firstname.lastname@example.org|
|Contact: J A Gietema, MD, PhD +31 50 3616161 email@example.com|
|Principal Investigator: A KL Reyners, MD, PhD|
|Principal Investigator:||A KL Reyners, MD, PhD||University Medical Center Groningen|