Palliation: the Effect of Education on Pain

NCT01358539 | Completed Phase 3 DMC

• 1 other identifier: ZonMW 11510007
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

palliation; pain education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• improvement of quality of life

  12 weeks

Study Arms (2)

Pain education

EXPERIMENTAL

Patients receiving pain education

Behavioral: Pain education

No Pain education

NO INTERVENTION

Control group, patients receiving no pain education

Interventions

Pain education BEHAVIORAL

Patients receiving pain education

Pain education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Kankerbestrijding: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Study Officials

• A KL Reyners, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NL (1)