We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760305
First Posted: September 26, 2008
Last Update Posted: May 24, 2011
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.
Information provided by:
Oslo University Hospital
September 25, 2008
September 26, 2008
May 24, 2011
October 2004
April 2008   (Final data collection date for primary outcome measure)
Worst pain intensity [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT00760305 on ClinicalTrials.gov Archive Site
Knowledge of cancer pain management [ Time Frame: 6 weeks ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
  • Cancer
  • Pain
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
  • Experimental: 1
    Patients who received the Pro-Self psychoeducational intervention
    Intervention: Behavioral: Pro self pain control programme
  • No Intervention: 2
    Patients who received standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
April 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00760305
158707/V10
No
Not Provided
Not Provided
Tone Rustøen professor, Oslo University College
Oslo University Hospital
Not Provided
Principal Investigator: Tone Rustoen, PhD Oslo University Hospital
Oslo University Hospital
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP