Pain Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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