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Pro-self Pain Management in Norway

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00760305
Acronym
Pro-self
Enrollment
167
Registered
2008-09-26
Start date
2004-10-31
Completion date
2008-04-30
Last updated
2011-05-24

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

Conditions

Cancer, Pain

Keywords

cancer pain, bone metastasis, patient education, psychoeducational education, side effects, analgesics

Brief 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.

Detailed 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.

Interventions

BEHAVIORALPro 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

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Worst pain intensity6 weeks

Secondary

MeasureTime frame
Knowledge of cancer pain management6 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026