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

NCT ID: NCT02035098

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-07-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

The Pac-IFicO programme

The Pac-IFicO programme is a complex interventions aimed at improving the quality of pain managementi in hospitalized patients.

Group Type: EXPERIMENTAL

the Pac-IFicO programme

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

WARD LEVEL

1. consent from the head of the ward to participate to the study;

2. ward classified as oncology, medicine, respiratory disease ward according to the regional classification of hospitals;

3. number of beds: ≥20 ;

4. number of ordinary admissions with primary or secondary diagnosis of tumour (ICD-IX 140-239) >180 per year;

5. yearly average stay in hospital between 4 and 19 days;

6. punctual prevalence of patients with primary or secondary diagnosis of tumour (ICD-IX 140-239) ≥ 8 patients.

STAFF LEVEL

1. affiliation to the ward;

2. informed consent to participate to the study.

PATIENT LEVEL

1. ordinarily admitted in the ward for at least 24 hours;

2. age ≥ 18 years

3. able to fill in the questionnaire according the profession judgment;

4. informed consent to participate to the study.

Exclusion Criteria

WARD LEVEL

1. the ward had received or is receiving quality improvement programme of staff education for improve pain control.

PATIENT LEVEL

1. patient already assessed in one of the previous assessments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlo Peruselli, MD

Role: PRINCIPAL_INVESTIGATOR

ASL Biella (Italy)

References

Ripamonti CI, Prandi C, Costantini M, Perfetti E, Pellegrini F, Visentin M, Garrino L, De Luca A, Pessi MA, Peruselli C. The effectiveness of the quality program Pac-IficO to improve pain management in hospitalized cancer patients: a before-after cluster phase II trial. BMC Palliat Care. 2014 Mar 29;13(1):15. doi: 10.1186/1472-684X-13-15.

Reference Type: DERIVED

PMID: 24678911 (View on PubMed)

Other Identifiers

RFPS-2006-6-341684

Identifier Type: -

Identifier Source: org_study_id