Pain education for patients with painful bone metastases undergoing palliative radiotherapy: reducing pain by increasing patient's knowledge and self-management.

Phase 3

Completed

Conditions: patiënten met pijnlijke botmetastasen als gevolg van een primaire solide maligniteit
painful bone metastases from cancer

Registration Number: NL-OMON43719

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 340

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study will investigate whether the Pain Education Program reduces pain<br /><br>intensity in patients with painful bone metastases referred for palliative<br /><br>short term radiotherapy. The primary endpoint of the proposed randomized<br /><br>multicenter study is a decrement of the number of patients whose worst pain<br /><br>intensity is 5 or higher during the 12 weeks after randomization with regard to<br /><br>the control group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-time to reach a worst pain intensity less than 5<br /><br>-mean pain intensity in both randomization arms during the study period<br /><br>-quality of life measures in both randomization arms<br /><br>-relation between pain intensity and quality of life measures<br /><br>-assessment whether baseline characteristics can predict which patients benefit<br /><br>from the nurse-led education<br /><br>- health state utility in both randomized arms<br /><br>- costs </p><br>