Pain Education for Patients With Painful Bone Metastases Undergoing Palliative Radiotherapy: Reducing Pain by Increasing Patient's Knowledge and Self-management
18 Years
80 Years
Both
Bone Metastases
Trial Information
Pain Education for Patients With Painful Bone Metastases Undergoing Palliative Radiotherapy: Reducing Pain by Increasing Patient's Knowledge and Self-management
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
a decrement of the number of patients whose worst pain intensity remains above 4
Outcome 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.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
A KL Reyners, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Medical Centre Groningen
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
ZonMW 11510007
NCT ID:
NCT01358539
Start Date:
September 2010
Completion Date:
December 2014
Related Keywords:
- Bone Metastases
- palliation
- pain education
- Neoplasm Metastasis
- Bone Neoplasms
- Bone Marrow Diseases
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