Clinical trial NCT00760305: Pro-self Pain Management in Norway
Official title: Pro-self - a Nursing Intervention to Support and Educate Cancer Patients and Their Caregivers so That the Patient Can Stay Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain
Keywords: cancer pain
bone metastasis
patient education
psychoeducational education
side effects
analgesics
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Worst pain intensity
timeFrame: 6 weeks
Secondary outcomes:
measure: Knowledge of cancer pain management
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Tone Rustoen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rustoen T, Lerdal A, Gay C, Kottorp A. Rasch analysis of the Herth Hope Index in cancer patients. Health Qual Life Outcomes. 2018 Oct 3;16(1):196. doi: 10.1186/s12955-018-1025-5.