CancerPhase 2/3NCT02035098
Improving Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial
A Phase 2/3 study testing the Pac-IFicO programme in people with Cancer, run by Azienda USL Reggio Emilia - IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- the Pac-IFicO programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jul 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 15Show fewer
- 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.
Who cannot join
- 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.
About this study
Official title: The Effectiveness of the Quality Program Pac-IficO to Improve Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial
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.
Read the 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
- Being tested
- the Pac-IFicO programme
- Keywords
- cancer, pain, cluster trial, quality improvement
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Pac-IFicO programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The Pac-IFicO programme | Experimental | The Pac-IFicO programme is a complex interventions aimed at improving the quality of pain managementi in hospitalized patients. Receives: Other: the Pac-IFicO programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 28±1 days after Pac-IficO completion.
Secondary outcomes (2)
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)
Measured: 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.
Measured: up to 28±1 days after Pac-IficO completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Carlo Peruselli, MD, Principal investigator, ASL Biella (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035098
- Sponsor's protocol ID
- RFPS-2006-6-341684
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24678911
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Quality Program Pac-IficO to Improve Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial
- ClinicalTrials.gov ID
- NCT02035098
- Acronym / sponsor ID
- RFPS-2006-6-341684
- Conditions
- Cancer
- Keywords
- cancer, pain, cluster trial, quality improvement
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Pac-IFicO programme | Experimental | Other: the Pac-IFicO programmeThe Pac-IFicO programme is a complex interventions aimed at improving the quality of pain managementi in hospitalized patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Pac-IFicO programmeThe 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. | Other | The Pac-IFicO programme |
Primary outcome
percentage of hospitalized cancer patients with average severe pain (score 7-10) within the latest 24 hours
Time frame: up to 28±1 days after Pac-IficO completion.
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.
2 secondary outcomes
knowledge of the ward professionals in pain management
Time frame: In the month before and in the month after the completion of the intervention.
quality of pain management in cancer patients
Time frame: up to 28±1 days after Pac-IficO completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Derived from this study: PubMed 24678911Ripamonti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Peruselli, MD principal investigator
ASL Biella (Italy)
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing the Pac-IFicO programme in people with Cancer, run by Azienda USL Reggio Emilia - IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of hospitalized cancer patients with average severe pain (score 7-10) within the latest 24 hours (time frame: up to 28±1 days after Pac-IficO completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02035098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.