Status and phase
Conditions
Treatments
About
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.
Full 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%.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria
WARD LEVEL
STAFF LEVEL
PATIENT LEVEL
Exclusion criteria
WARD LEVEL
PATIENT LEVEL
Primary purpose
Allocation
Interventional model
Masking
504 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal