Palliation: the Effect of Education on Pain (PEEP)

Pain Education for Patients With Painful Bone Metastases Undergoing Palliative Radiotherapy: Reducing Pain by Increasing Patient's Knowledge and Self-management

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 Overview

• Status: Completed
• Conditions: Bone Metastases
• Intervention / Treatment: Behavioral: Pain education

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older
• uncomplicated painful bone metastases
• primary malignancy is a solid tumour
• pain intensity on a numeric rating scale of 5 or higher
• indication for short-term radiotherapy
• able to fill out Dutch questionnaires
• able to follow instructions
• informed consent provided

Exclusion Criteria:

• Hematological malignancy
• Long-term schedule radiotherapy
• Life expectancy shorter than three months
• Karnofsky Performance Score of 40 or less

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a decrement of the number of patients whose worst pain intensity remains above 4	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
improvement of quality of life	12 weeks

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Kankerbestrijding
• Investigators: Principal Investigator: A KL Reyners, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimated): May 23, 2011

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: palliation; pain education
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: ZonMW 11510007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No