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

18 Years
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Cancer, Pain

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Worst pain intensity

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Tone Rustoen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital


Norway: Data Protection Authority

Study ID:




Start Date:

October 2004

Completion Date:

April 2008

Related Keywords:

  • Cancer
  • Pain
  • cancer pain
  • bone metastasis
  • patient education
  • psychoeducational education
  • side effects
  • analgesics