Tone Rustøen1, Berit T Valeberg, Eva Kolstad, Erik Wist, Steven Paul, Christine Miaskowski. 1. Author affiliations: Division of Emergencies and Critical Care, Department of Research and Development (Dr Rustøen), and Cancer Clinic (Ms Kolstad and Dr Wist), Oslo University Hospital, Ullevål; Institute of Health and Society, Department of Nursing Science, University of Oslo (Dr Rustøen); Oslo University College, Faculty of Nursing (Dr Valeberg), Norway; and Department of Physiological Nursing, University of California, San Francisco (Drs Paul and Miaskowski).
Abstract
BACKGROUND: The undertreatment of cancer pain remains a significant clinical problem. OBJECTIVE: The aim of this randomized controlled trial was to evaluate the efficacy of the PRO-SELF Pain Control Program that was modified for Norwegian cancer patients in decreasing pain and increasing opioid intake compared with control care. INTERVENTIONS/ METHODS:Oncology outpatients with pain from bone metastasis were randomized into the PRO-SELF (n = 87) or control (n = 92) groups. A nurse visited patients in the PRO-SELF group in their home at weeks 1, 3, and 6 and conducted telephone interviews at weeks 2, 4, and 5. Patients in both groups completed a daily diary of pain intensity ratings and analgesic intake. RESULTS: For both groups, significant decreases in pain intensity scores and in hours per day in pain (both, P < .001) were found over the 6 weeks of the study. However, no significant group × time interactions were found for any of the pain measures. In both groups, total dose of opioid taken increased over time. However, no significant group × time interactions were found for changes over time in the total dose, around-the-clock dose, or as-needed dose of opioid analgesics taken. CONCLUSIONS: Possible reasons for the lack of efficacy include an inadequate dose of the psychoeducational intervention, inadequate changes in analgesic prescriptions, and/or the impact of attention provided to the control group. IMPLICATIONS FOR PRACTICE: Coaching, nursing support, and the use of a pain diary may be important interventions to reduce pain intensity.
RCT Entities:
BACKGROUND: The undertreatment of cancer pain remains a significant clinical problem. OBJECTIVE: The aim of this randomized controlled trial was to evaluate the efficacy of the PRO-SELF Pain Control Program that was modified for Norwegian cancerpatients in decreasing pain and increasing opioid intake compared with control care. INTERVENTIONS/ METHODS: Oncology outpatients with pain from bone metastasis were randomized into the PRO-SELF (n = 87) or control (n = 92) groups. A nurse visited patients in the PRO-SELF group in their home at weeks 1, 3, and 6 and conducted telephone interviews at weeks 2, 4, and 5. Patients in both groups completed a daily diary of pain intensity ratings and analgesic intake. RESULTS: For both groups, significant decreases in pain intensity scores and in hours per day in pain (both, P < .001) were found over the 6 weeks of the study. However, no significant group × time interactions were found for any of the pain measures. In both groups, total dose of opioid taken increased over time. However, no significant group × time interactions were found for changes over time in the total dose, around-the-clock dose, or as-needed dose of opioid analgesics taken. CONCLUSIONS: Possible reasons for the lack of efficacy include an inadequate dose of the psychoeducational intervention, inadequate changes in analgesic prescriptions, and/or the impact of attention provided to the control group. IMPLICATIONS FOR PRACTICE: Coaching, nursing support, and the use of a pain diary may be important interventions to reduce pain intensity.