Palliation: the Effect of Education on Pain (PEEP)
Primary Purpose
Bone Metastases
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Pain education
Sponsored by
About this trial
This is an interventional supportive care trial for Bone Metastases focused on measuring palliation, pain education
Eligibility 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
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pain education
No Pain education
Arm Description
Patients receiving pain education
Control group, patients receiving no pain education
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
improvement of quality of life
Full Information
NCT ID
NCT01358539
First Posted
May 19, 2011
Last Updated
February 1, 2021
Sponsor
University Medical Center Groningen
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Kankerbestrijding
1. Study Identification
Unique Protocol Identification Number
NCT01358539
Brief Title
Palliation: the Effect of Education on Pain
Acronym
PEEP
Official Title
Pain Education for Patients With Painful Bone Metastases Undergoing Palliative Radiotherapy: Reducing Pain by Increasing Patient's Knowledge and Self-management
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Kankerbestrijding
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases
Keywords
palliation, pain education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain education
Arm Type
Experimental
Arm Description
Patients receiving pain education
Arm Title
No Pain education
Arm Type
No Intervention
Arm Description
Control group, patients receiving no pain education
Intervention Type
Behavioral
Intervention Name(s)
Pain education
Intervention Description
Patients receiving pain education
Primary Outcome Measure Information:
Title
a decrement of the number of patients whose worst pain intensity remains above 4
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
improvement of quality of life
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A KL Reyners, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Palliation: the Effect of Education on Pain
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