Palliation: the Effect of Education on Pain (PEEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Medical Centre Groningen
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Kankerbestrijding
Information provided by (Responsible Party):
A.K.L. Reyners, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01358539
First received: May 19, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Bone Metastases
Behavioral: Pain education
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • improvement of quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358539

Contacts
Contact: A KL Reyners, MD, PhD +31503616161 a.k.l.reyners@umcg.nl
Contact: J A Gietema, MD, PhD +31 50 3616161 j.a.gietema@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: A KL Reyners, MD, PhD    +31 50 3616161    a.k.l.reyners@umcg.nl   
Contact: J A Gietema, MD, PhD    +31 50 3616161    j.a.gietema@umcg.nl   
Principal Investigator: A KL Reyners, MD, PhD         
Sponsors and Collaborators
University Medical Centre Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Kankerbestrijding
Investigators
Principal Investigator: A KL Reyners, MD, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: A.K.L. Reyners, Medical Oncologist, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01358539     History of Changes
Other Study ID Numbers: ZonMW 11510007
Study First Received: May 19, 2011
Last Updated: June 2, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
palliation
pain education

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Neoplasm Metastasis
Bone Diseases
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014