Pro-self Pain Management in Norway (Pro-self)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00760305
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : May 24, 2011
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer Pain Behavioral: Pro self pain control programme Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Pro-self - a Nursing Intervention to Support and Educate Cancer Patients and Their Caregivers so That the Patient Can Stay Home
Study Start Date : October 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1
Patients who received the Pro-Self psychoeducational 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

No Intervention: 2
Patients who received standard care

Primary Outcome Measures :
  1. Worst pain intensity [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Knowledge of cancer pain management [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00760305

Ulleval University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Tone Rustoen, PhD Oslo University Hospital

Responsible Party: Tone Rustøen professor, Oslo University College Identifier: NCT00760305     History of Changes
Other Study ID Numbers: 158707/V10
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: September 2008

Keywords provided by Oslo University Hospital:
cancer pain
bone metastasis
patient education
psychoeducational education
side effects