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.
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%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
504
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.
percentage of hospitalized cancer patients with average severe pain (score 7-10) within the latest 24 hours
All eligible patients will be assessed in the month before (the before sample) and in the month after the implementation of the intervention (the after sample). For both samples the outcomes are composite measures from the five assessments in the month before and from five assessments in the month after. Each outcome results from the sum of patients with severe pain in the five assessments (the numerator) divided the total number of assessed patients in the five assessments (the denominator) x 100.
Time frame: up to 28±1 days after Pac-IficO completion.
knowledge of the ward professionals in pain management
Knowledge of the ward professionals in pain management were assessed before and after the implementation of the intervention by administering the Italian version of the Pain Attitudes and Knowledge Scale (PAK)
Time frame: In the month before and in the month after the completion of the intervention.
quality of pain management in cancer patients
All eligible patients will be assessed in the month before (the before sample) and in the month after the implementation of the intervention (the after sample). For both samples the outcomes are composite measures from the five assessments in the month before and from five assessments in the month after. Each outcome results from the sum of patients with severe pain in the five assessments (the numerator) divided the total number of assessed patients in the five assessments (the denominator) x 100.
Time frame: up to 28±1 days after Pac-IficO completion
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