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

NCT02035098 | Completed Phase 2

• 1 other identifier: RFPS-2006-6-341684
• Study Type: interventional
• Target: 504
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Keywords

cancer, pain, cluster trial, quality improvement

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 28±1 days after Pac-IficO completion.

Secondary Outcomes (2)

• knowledge of the ward professionals in pain management

  In the month before and in the month after the completion of the intervention.

• quality of pain management in cancer patients

  up to 28±1 days after Pac-IficO completion

Study Arms (1)

The Pac-IFicO programme

EXPERIMENTAL

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

Other: the Pac-IFicO programme

Interventions

the Pac-IFicO programme 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.

The Pac-IFicO programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• WARD LEVEL
• consent from the head of the ward to participate to the study;
• ward classified as oncology, medicine, respiratory disease ward according to the regional classification of hospitals;
• number of beds: ≥20 ;
• number of ordinary admissions with primary or secondary diagnosis of tumour (ICD-IX 140-239) \>180 per year;
• yearly average stay in hospital between 4 and 19 days;
• punctual prevalence of patients with primary or secondary diagnosis of tumour (ICD-IX 140-239) ≥ 8 patients.
• STAFF LEVEL
• affiliation to the ward;
• informed consent to participate to the study.
• PATIENT LEVEL
• ordinarily admitted in the ward for at least 24 hours;
• age ≥ 18 years
• able to fill in the questionnaire according the profession judgment;
• informed consent to participate to the study.

You may not qualify if:

• WARD LEVEL
• \. the ward had received or is receiving quality improvement programme of staff education for improve pain control.
• PATIENT LEVEL
• \. patient already assessed in one of the previous assessments.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Related Publications (1)

• 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.

  PMID: 24678911 DERIVED

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlo Peruselli, MD

  ASL Biella (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: January 14, 2014
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 11, 2025

Record last verified: 2013-11