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

Pain education for patients with painful bone metastases undergoing palliative radiotherapy: reducing pain by increasing patient's knowledge and self-management. - Palliation: the effect of education on pain (PEEP)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43719
Enrollment
340
Registered
2010-11-04
Start date
2011-03-16
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

A pain education program.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)