Survey on symptoms in patients receiving chemotherapy in an Italian department of oncology: a comparison between period prevalences.

PURPOSE: The purpose of this study is to evaluate the prevalence over time of the measured side effects using a self-assessment questionnaire in normal clinical practice. METHODS: The prevalence of symptoms reported by patients on the questionnaire was evaluated over two 1-year periods: from 1 June 2006 to 31 May 2007 and from 1 July 2013 to 30 June 2014. Descriptive statistics were used to describe population. The 2006-2007 and 2013-2014 datasets were compared with each other using the chi-squared test for equality of proportion, Pearson's chi-squared test, and chi-squared test for trend in proportion. RESULTS: We analyzed 1974 questionnaires from 283 patients in 2006-2007 and 2619 questionnaires from 403 patients in 2013-2014. The most frequently encountered symptom in both periods was fatigue; nausea and constipation decreased in 2013-2014 compared with 2006-2007, while alopecia increased. CONCLUSIONS: Using the self-assessment questionnaire in normal clinical practice has allowed us to carry out an accurate prevalence survey on symptoms in patients receiving chemotherapy that takes into account not only reports of the presence of symptoms but also of their absence. Between 2006-2007 and 2013-2014, there was an increase in patients treated at the Oncological Day Hospital of the Biella Hospital, whose characteristics were comparable in the two periods, except for the type of therapies carried out. Some symptoms were in decline: fatigue, nausea, and constipation.

The effectiveness of the quality program Pac-IficO to improve pain management in hospitalized cancer patients: a before-after cluster phase II trial.

BACKGROUND: 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 (HCPs) 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. METHODS/DESIGN: This is a before-after cluster phase II study. After the before assessment, the experimental intervention - 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 intervention 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 program 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, and quality of pain management. We plan to recruit about 500 cancer patients. This sample size should be sufficient, after appropriate statistical adjustments for clustering, to detect an absolute decrease in the primary end-point from 20% to 9%. DISCUSSION: This trial is aimed at exploring with an experimental approach the efficacy of a new quality improvement educational intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02035098.

Benign breast diseases in breast cancer screening programs in Italy (2000-2001).

AIMS AND BACKGROUND: Screening mammography has been shown to be effective in reducing breast cancer mortality in several randomized clinical trials. One major side effect of screening is the diagnosis of benign breast disease (BBD), which is considered as a nonprogressive lesion, except for a small percentage of lesions considered at high risk. We present data referring to service screening programs active in Italy in 2000 and 2001 and participating in the national survey carried out by the Italian Group for Mammography Screening (GISMa). METHODS: To all centers participating in the GISMa National Survey, we submitted a questionnaire regarding the service screening protocol and main indicators of performance of the local program in the years 2000 and 2001. RESULTS: A total of 657 detected BBD cases, registered by 23 Italian breast cancer screening centers in women 50 to 69 years of age, are included in this study. The BBD detection rate was 2.5 per 1000 at the first screening test and 1.05 per 1000 at repeated tests. The benign/malignant ratio was 0.34 at the first and 0.22 at the repeated test. CONCLUSIONS: Detection of BBD occurred frequently in breast screening programs, and prognostic implications should be further investigated. Women should be individually informed at screening, and with greater detail at the moment of the recall for assessment, of the implications of BBD detection and receive the necessary, also psychological, counseling to avoid the possible harm related to breast cancer screening.

The late complications of totally implantable central venous access ports: the results from an Italian multicenter prospective observation study.

PURPOSE: The principal aim of this study is to analyze the incidence of late complications in oncologic patients with totally implanted central venous access ports. METHODS: A prospective multicenter observational study was conducted in 26 Italian oncologic outpatient clinics. 1076 cancer patients with Totally Implanted Central Venous Access Ports (TIAP) were observed. 515 devices were observed in patients under treatment and 561 in patients who went to the outpatient clinic only for flushing. RESULTS: Late complications observed in patients under treatment were: 3 pocket infections (0.09/1000 days of port observation), 1 cutaneous infection (0.03/1000 days of port observation), 8 occlusions (0.24/1000 days of port observation) and 12 others. In patients using the device only for flushing we observed 4 cases of device related bacteremia (0.04/1000 days of port observation), 1 pocket infection (0.01/1000 days of port observation), 1 cutaneous infection (0.01/1000 days of port observation), 3 occlusions (0.03/1000 days of port observation) and 7 other complications. CONCLUSIONS: The low incidence of complications suggests that TIAP is safe and reliable for long term intermittent venous access. Our results support the use of TIAP in the oncology patients.