NCT02035098

Improving Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial

The Effectiveness of the Quality Program Pac-IficO to Improve Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in improving the quality of pain management in hospitalised cancer patients. This is a before-after cluster phase II study performed in medicine, oncology and respiratory disease hospital wards. The Pac-IFicO programme is a complex interventions with multiple components. The primary end-point of the study is the proportion of cancer patients with severe pain.

Detailed description

Cancer-related pain continues to be a major healthcare issue worldwide. Despite the availability of effective analgesic drugs, published guidelines and educational programs for Health Care Professionals the symptom is still under-diagnosed and its treatment is not appropriate in many patients. The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in improving the quality of pain management in hospitalised cancer patients. This is a before-after cluster phase II study. After the before assessment, the Pac-IFicO programme will be implemented in ten medicine, oncology and respiratory disease hospital wards. The same assessment will be repeated after the completion of the intervention. The Pac-IFicO programme is a complex interventions with multiple components. It includes focus group with ward professionals for identifying possible local obstacles to optimal pain control, informative material for the patients, an educational programs performed through guides from the wards, and an organisational intervention to the ward. The primary end-point of the study is the proportion of cancer patients with severe pain. Secondary end-points include opioids administered in the wards, knowledge in pain management, quality of pain management. We plan to recruit about 500 cancer patients from ten hospital wards. This sample size should be sufficient, after appropriate statistical adjustments for clustering, to detect an absolute decrease in the proportion of cancer patients with severe pain (the primary end-point) from 20% to 9%.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	the Pac-IFicO programme	The Pac-IFicO programme is a complex interventions with multiple components. It includes focus group with ward professionals for identifying possible local obstacles to optimal pain control, informative material for the patients, an educational programs performed through guides from the wards, and an organisational intervention to the ward.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2014-01-14
• Last updated: 2025-06-11