Pro-self Pain Management in Norway

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00760305
First received: September 25, 2008
Last updated: May 23, 2011
Last verified: September 2008
  Purpose

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 Intervention
Cancer
Pain
Behavioral: Pro self pain control programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Worst pain intensity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge of cancer pain management [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 167
Study Start Date: October 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760305

Locations
Norway
Ulleval University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Tone Rustoen, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Tone Rustøen professor, Oslo University College
ClinicalTrials.gov Identifier: NCT00760305     History of Changes
Other Study ID Numbers: 158707/V10
Study First Received: September 25, 2008
Last Updated: May 23, 2011
Health Authority: Norway: Data Protection Authority

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

ClinicalTrials.gov processed this record on October 01, 2014