Palliation: the Effect of Education on Pain

Summary

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.

Conditions

• Bone Metastases

Interventions

BEHAVIORAL

Pain education

Patients receiving pain education

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Kankerbestrijding

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• A KL Reyners, MD, PhD · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Netherlands

Study Locations