A qualitative analysis and development of a conceptual model assessing financial toxicity in cancer patients accessing the universal healthcare system.

PURPOSE: This paper illustrates a conceptual model for a new patient-reported outcome measure (PROM) aimed at measuring financial toxicity (FT) in oncological setting in Italy, where citizens are provided universal healthcare coverage. METHODS: Focus groups with overall 34 patients/caregivers in three different Italian centers (from Northern, Centre, and Southern Italy) and an open-ended survey with 97 medical oncologists were undertaken. Transcripts from focus groups and the open-ended survey were analyzed to identify themes and links between themes. Themes from the qualitative research were supplemented with those reported in the literature; concepts identified formed the basis for item development that were then tested through the importance analysis (with 45 patients) and the cognitive debriefing (with other 45 patients) to test relevance and comprehension of the first draft PRO instrument. RESULTS: Ten domains were extracted by analyzing 156 concepts generated from focus groups and the open-ended survey. After controlling for redundancy, 55 items were generated and tested through the importance analysis. After controlling comprehension and feasibility through cognitive debriefing interviews, a first version of the questionnaire consisting of 30 items was devised. CONCLUSIONS: This qualitative study represents the first part of a study conducted to develop a new PROM to assess FT in Italy, by using a bottom-up approach that makes the most of patients' experiences and the health system analysis. TRIAL REGISTRATION: clinicaltrials.gov NCT03473379 first posted on March 22, 2018.

Nutritional Support in Cancer patients: update of the Italian Intersociety Working Group practical recommendations.

Malnutrition is a frequent problem in cancer patients, which leads to prolonged and repeated hospitalizations, increased treatment-related toxicity, reduced response to cancer treatment, impaired quality of life, a worse overall prognosis and the avoidable waste of health care resources. Despite being perceived as a limiting factor in oncologic treatments by both oncologists and patients, there is still a considerable gap between need and actual delivery of nutrition care, and attitudes still vary considerably among health care professionals. In the last 5 years, the Italian Intersociety Working Group for Nutritional Support in Cancer Patients (WG), has repeatedly revisited this issue and has concluded that some improvement in nutritional care in Italy has occurred, at least with regard to awareness and institutional activities. In the same period, new international guidelines for the management of malnutrition and cachexia have been released. Despite these valuable initiatives, effective structural strategies and concrete actions aimed at facing the challenging issues of nutritional care in oncology are still needed, requiring the active participation of scientific societies and health authorities. As a continuation of the WG's work, we have reviewed available data present in the literature from January 2016 to September 2021, together with the most recent guidelines issued by scientific societies and health authorities, thus providing an update of the 2016 WG practical recommendations, with suggestions for new areas/issues for possible improvement and implementation.

Nutritional care in cancer patients: Initiatives and perspectives of the Italian Intersociety Working Group for Nutritional Support in Cancer Patients.

Malnutrition is a frequent comorbidity in people with cancer, associated with poor tolerance of anticancer treatments, prognosis, and quality of life. Despite the abundance of scientific literature supporting this evidence and the availability of international guidelines for managing nutritional care in people with cancer, attitudes about this issue still vary considerably among oncologists, to the point that many patients who are malnourished do not receive adequate nutritional support. In view of this, the Italian Association of Medical Oncology, the Italian Society of Artificial Nutrition and Metabolism, and the Italian Federation of Volunteer-based Cancer Organizations implemented in 2016 a collaborative working group and initiated a structured project called Integrating Nutritional Therapy in Oncology, with the aim of increasing oncologists' awareness of nutritional issues and consequently improving the nutritional care of cancer patients in Italy. In 2019, the Italian Society of Oncological Surgery and the Technical Scientific Association of Food, Nutrition and Dietetics joined the working group. In this article, we present the updated initiatives and the perspectives of this intersociety project.

Cross-sectional study to develop and describe psychometric characteristics of a patient-reported instrument (PROFFIT) for measuring financial toxicity of cancer within a public healthcare system.

OBJECTIVES: To measure and explain financial toxicity (FT) of cancer in Italy, where a public healthcare system exists and patients with cancer are not expected (or only marginally) to pay out-of-pocket for healthcare. SETTING: Ten clinical oncological centres, distributed across Italian macroregions (North, Centre, South and Islands), including hospitals, university hospitals and national research institutes. PARTICIPANTS: From 8 October 2019 to 11 December 2019, 184 patients, aged 18 or more, who were receiving or had received within the previous 3 months active anticancer treatment were enrolled, 108 (59%) females and 76 (41%) males. INTERVENTION: A 30-item prefinal questionnaire, previously developed within the qualitative tasks of the project, was administered, either electronically (n=115) or by paper sheet (n=69). PRIMARY AND SECONDARY OUTCOME MEASURES: According to the protocol and the International Society for Pharmacoeconomics and Outcomes Research methodology, the final questionnaire was developed by mean of explanatory factor analysis and tested for reliability, internal consistency (Cronbach's α test and item-total correlation) and stability of measurements over time (test-retest reliability by intraclass correlation coefficient and weighted Cohen's kappa coefficient). RESULTS: After exploratory factor analysis, a score measuring FT (FT score) was identified, made by seven items dealing with outcomes of FT. The Cronbach's alpha coefficient for the FT score was 0.87 and the item-total correlation coefficients ranged from 0.53 to 0.74. Further, nine single items representing possible determinants of FT were also retained in the final instrument. Test-retest analysis revealed a good internal validity of the FT score and of the 16 items retained in the final questionnaire. CONCLUSIONS: The Patient-Reported Outcome for Fighting FInancial Toxicity (PROFFIT) instrument consists of 16 items and is the first reported instrument to assess FT of cancer developed in a country with a fully public healthcare system. TRIAL REGISTRATION NUMBER: NCT03473379.

Cancer-related malnutrition management: A survey among Italian Oncology Units and Patients' Associations.

Attitudes toward cancer-related malnutrition vary considerably among oncologists and nutritional support is often not handled according to the available guidelines. The Italian Association of Medical Oncology (AIOM), Italian Society of Artificial Nutrition and Metabolism (SINPE), Italian Federation of Volunteer-based Cancer Organizations (FAVO), and Fondazione AIOM Working Group conducted a national web-based survey addressed to all Italian Oncology Units referees and Italian Cancer Patients Associations. The aim was to investigate the current management of malnutrition and views on nutritional care among oncologists and patients. One hundred and seventy-one (51.6%) of the 331 registered Italian Oncology Units and 75 (38.5%) of the 195 FAVO local communities participated in the survey. Nutritional assessment and support were integrated into patient care from diagnosis for 35% of Oncology Unit referees and 15% of FAVO associates. According to 42% of oncologists, nutritional assessment was carried out only after patients requested it, while it was not performed at all for 45% of FAVO associates. Almost 60% of patient affiliates were not aware of clinical referrals for home artificial nutrition management. However, for almost all responders, the evaluation of nutritional status was considered crucial in predicting tolerance to anticancer treatment. Although malnutrition was considered a limiting factor in oncology treatments by both oncologists and patients, nutritional care practices still appear largely inappropriate. Attitudes differ between oncologists and patients, the latter reporting a more dissatisfied picture. Improving nutritional care in oncology remains a challenging task.

Development and validation of a patient-reported outcome tool to assess cancer-related financial toxicity in Italy: a protocol.

INTRODUCTION: Financial toxicity (FT) is a well-recognised problem in oncology. US-based studies have shown that: (a) cancer patients have a 2.7 times risk of bankruptcy; (b) patients who declare bankruptcy have a 79% greater hazard of death; (c) financial burden significantly impairs quality of life (QoL) and (d) reduces compliance and adherence to treatment prescriptions. The aim of the project is to develop and validate a patient-reported-outcome (PRO) measure to assess FT of cancer patients in Italy, where, despite the universal health coverage provided by the National Health Service, FT is an emerging issue. METHODS AND ANALYSIS: Our hypothesis is that a specific FT measure, which considers the relevant sociocultural context and healthcare system, would allow us to understand the main determinants of cancer-related FT in Italy, in order to address and reduce these factors. According to the International Society for Pharmaco-economics and Outcomes Research guidelines on PROs, the project will include the following steps: (1) concept elicitation (from focus groups with patients and caregivers; literature; oncologists; nurses) and analysis, creating a coding library; (2) item generation (using a format that includes a question and a response on a 4-point Likert scale) and analysis through patients' cognitive interviews of item importance within different coding categories to produce the draft instrument; (3) factor analysis and internal validation (with Cronbach's alpha and test-retest for reliability) to produce the final instrument; (4) external validation with QoL anchors and depression scales. The use of the FT measure in prospective trials is also planned. ETHICS AND DISSEMINATION: The protocol is approved by the ethical committees of all the participating centres. The project will tentatively produce a validated tool by the spring 2021. The project might also represent a model and the basis for future cooperation with other European countries, with different healthcare systems and socioeconomic conditions. TRIAL REGISTRATION NUMBER: NCT03473379.

Changes in food habits in cancer patients in Italy: a survey. AIOM - SINPE - FAVO.

OBJECTIVES: The aim of this study was to investigate the prevalence of cancer patients changing their diet in relation to cancer site, sex, age and geographic distribution. Furthermore, we aimed to explore the rationale behind dietary changes and to identify sources of information in order to plan specific educational training. METHODS: Patients ≥18 y of age who accessed the Italian Cancer Patients, Families and Friends Association information points were invited to participate. An ad hoc self-report questionnaire was used. The questionnaire asked patients about changes made to the major food groups. A minimum sample of 100 patients for the most common cancers was planned. We analyzed 1257 questionnaires. We assessed the prevalence of, reasons for, and type of dietary changes. Logistic regression was used to analyze the main determinants of dietary changes. RESULTS: Of the 1257 patients, 705 (56.1%) reported changes since receiving the diagnosis of cancer. On the logistic regression analysis, age and tumor site were significantly associated with dietary changes (P <0.001), mainly in patients <50 y of age and in those with upper gastrointestinal cancers. Slightly more than half (50.8%) of patients adopted a healthier diet, with 31.3% doing so to deal with eating-related side effects and 17.9% due to cancer sites. Regardless of the reasons for changing, the most common food items to result in a decrease in consumption were alcohol, red and processed meats, and sugary drinks. Only 15% of patients reported receiving specific nutrition indication. CONCLUSION: Italian patients are attentive to the importance of diet during cancer treatment. Personal choices reflect some indications for cancer prevention as there is still a shortage of guidelines for a correct diet during treatment. Nutrition indications are rarely given within the oncologic center.