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NCT00760305 Clinical Trial

Pro-self Pain Management in Norway

Pain Clinical Trial

— Pro-self  

Official title:
Pro-self - a Nursing Intervention to Support and Educate Cancer Patients and Their Caregivers so That the Patient Can Stay Home

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00760305
Other study ID # 158707/V10
Secondary ID
Status Completed
Phase N/A
First received September 25, 2008
Last updated May 23, 2011
Start date October 2004
Est. completion date April 2008

Study information
Verified date September 2008
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Data Protection Authority
Study type Interventional

Clinical Trial Summary

The main aim of this study is to evaluate whether a patient education programme on cancer pain management compared to standard care decreases pain and increases patients quality of life. The investigators hypothesis is that patients and family caregivers who receive the intervention will have improved outcomes. Patients and family members are seen in their homes by the nurses doing the intervention over 6 weeks. Patients keep a diary of their pain and medication intake.

Description:

The undertreatment of cancer pain remains a significant clinical problem. The PRO-SELF Pain Control Program is a 6 week psychoeducational intervention that was shown to improve pain management in oncology outpatients with pain from bone metastasis. However, this promising intervention requires replication in samples of oncology patients with cancer pain outside of the United States.

The purpose of the study was to test the effectiveness of The PRO-SELF Pain Control Program in Norwegian cancer patients and their family caregivers. Only data on patient outcomes will be presented.

The theoretical framework for this study incorporated elements of Orem's self-care theory, as well as the principles of academic detailing and nurse coaching to change patients' self-care behaviors regarding cancer pain management.

Two hundred adult cancer patients with pain from skeletal metastasis and their caregivers participated in this study. Patients were randomized to either the PRO-SELF program or standard care. Patients completed questionnaires about pain, physical functioning, quality of life, anxiety, and depression at the time of enrollment and after 6 weeks. Data on analgesics were collected through chart reviews and patient diaries. Both groups received home visits and telephone calls by an oncology nurse over a period of six weeks. Participants in the intervention group received education about pain management and were coached to improve their pain management behaviors. Two-way repeated measures analyses of variance will be done to determine differences in pain intensity scores and to evaluate the differences over time in the total amount of opioid analgesics taken by the patients.

Recruitment information / eligibility
Status Completed
Enrollment 167
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Greater than 18 years of age

- Radiographic evidence of bone metastasis

- Able to read and write Norwegian

- Average pain intensity of greater than 2.5

Exclusion Criteria:

- Brain metastasis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• Pro self pain control programme
A 6 week psychoeducational programme that included three home visits and three phone calls. Patients were taught about pain medication and side effects and about incorrect information regarding cancer pain management

Locations
Country Name City State
Norway Ulleval University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Worst pain intensity 6 weeks No
Secondary Knowledge of cancer pain management 6 weeks No
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