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IntroductionONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours.Methods and analysisThis is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher’s exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs.Ethics and disseminationEthical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations.Protocol versionVersion 2, 6 April 2021.Trial registration numberNCT04826458.

Background Accurate medication reconciliation reduces the risk of drug incompatibilities and adverse events that can occur during transitions in care. Community pharmacies (CPs) are a crucial part of the health care system and could be involved in collecting essential information on conventional and supplementary drugs used at home. Objective The aim of this paper was to establish an alliance between our cancer institute, Istituto Romagnolo per lo Studio dei Tumori (IRST), and CPs, the latter entrusted with the completion of a pharmacological recognition survey. We also aimed to integrate the national information technology (IT) platform of CPs with the electronic medical records of IRST. Methods Cancer patients undergoing antiblastic treatments were invited to select a CP taking part in the study and to complete the pharmacological recognition step. The information collected by the pharmacist was sent to the electronic medical records of IRST through the new IT platform, after which the oncologist performed the reconciliation process. Results A total of 66 CPs completed surveys for 134 patients. An average of 5.9 drugs per patient was used at home, with 12 or more used in the most advanced age groups. Moreover, 60% (80/134) of the patients used nonconventional products or critical foods. Some potential interactions between nonconventional medications and cancer treatments were reported. Conclusions In the PROF-1 (Progetto di Rete in Oncologia con le Farmacie di comunità della Romagna) study, an alliance was created between our cancer center and CPs to improve medication reconciliation, and a new integrated IT platform was validated. Trial Registration ClinicalTrials.gov NCT04796142; https://clinicaltrials.gov/ct2/show/NCT04796142

BACKGROUND Accurate medication reconciliation reduces the risk of drug incompatibilities and adverse events that can occur during transitions in care. Community pharmacies (CPs) are a crucial part of the health care system and could be involved in collecting essential information on conventional and supplementary drugs used at home. OBJECTIVE The aim of this paper was to establish an alliance between our cancer institute, Istituto Romagnolo per lo Studio dei Tumori (IRST), and CPs, the latter entrusted with the completion of a pharmacological recognition survey. We also aimed to integrate the national information technology (IT) platform of CPs with the electronic medical records of IRST. METHODS Cancer patients undergoing antiblastic treatments were invited to select a CP taking part in the study and to complete the pharmacological recognition step. The information collected by the pharmacist was sent to the electronic medical records of IRST through the new IT platform, after which the oncologist performed the reconciliation process. RESULTS A total of 66 CPs completed surveys for 134 patients. An average of 5.9 drugs per patient was used at home, with 12 or more used in the most advanced age groups. Moreover, 60% (80/134) of the patients used nonconventional products or critical foods. Some potential interactions between nonconventional medications and cancer treatments were reported. CONCLUSIONS In the PROF-1 (Progetto di Rete in Oncologia con le Farmacie di comunità della Romagna) study, an alliance was created between our cancer center and CPs to improve medication reconciliation, and a new integrated IT platform was validated. CLINICALTRIAL ClinicalTrials.gov NCT04796142; https://clinicaltrials.gov/ct2/show/NCT04796142

BACKGROUND The use of oral treatments is constantly growing in the area of onco-hematology, raising adherence and safety issues. There is an increasing body of literature highlighting the importance of patient empowerment in the self-management of cancer therapies. Within this scenario, the ONCO-TreC platform was customized and fine-tuned through a prospective multicenter training-validation study in cancer patients treated with oral anticancer drugs. OBJECTIVE This prospective randomized trial was designed to compare the effectiveness of two different strategies, ie, an electronic diary (ONCO-TreC) and a paper diary, for the management of oral cancer treatments in patients with solid and hematological tumors. METHODS Ad hoc strategies are planned to measure and monitor adherence to treatment and to assess usability and acceptability of the electronic diary. Informed consent will be obtained from all study participants. RESULTS This innovative eHealth system is expected to contribute to increasing the adherence to and safety of cancer care, promoting patient empowerment and improving patient-doctor communication. Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol no. 2982/2020; reference no. 2108). CONCLUSIONS Findings will be disseminated through peer-reviewed journals, conferences and event presentations. CLINICALTRIAL ClinicalTrials.gov NCT04826458; Institutional ID no. IRST100.28

to examine the factors that, in the context of the current pandemic, have influenced the conduct of a randomized clinical trial on hydroxychloroquine in Italy.the trend of enrolment in the PROTECT study, "A randomized study with Hydroxychloroquine versus observational support for prevention or early phase treatment of Coronavirus disease (COVID-19)" (Eudract number: 2020-001501-24, NCT04363827), conducted in the period from May to September 2020, was analysed to evaluate the possible association of the enrolment rate with the amount of information published in the national and local press on hydroxychloroquine.the PROTECT clinical study is an Italian interventional superiority study, open label, with cluster randomization, aimed at evaluating whether treatment with hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in a population of subjects exposed to SARS-CoV-2 virus consisting of cohabitants/contacts of COVID-19 patients and asymptomatic or paucisymptomatic subjects diagnosed with COVID-19.the number of asymptomatic or paucisymptomatic COVID-19 patients and the number of contacts/cohabitants of COVID-19 patients enrolled in the Protect study from May to September 2020.from May to September 2020, the number of patients diagnosed with COVID-19 enrolled in the PROTECT clinical trial showed a decrease consistent with the number of news on hydroxychloroquine appearing in the national and local press, starting from the time when the first criticisms of the efficacy of hydroxychloroquine were made known; the number of contacts/cohabitants of COVID-19 patients showed a more marked and more timely decrease.in the context determined by the current COVID-19 pandemic, conducting a controlled clinical trial is strongly influenced by public opinion on scientific issues. Adherence to a clinical study can become highly problematic and invalidate the possibility of answering a scientific question and the validity of a project. In the current pandemic situation, randomized controlled trials may not always be the optimal tool to reach the expected scientific evidence, due to a number of problems. It is preferable to use a sequential or adaptive design. Furthermore, study protocols should implement innovative approaches that also include the involvement of participants in the decision-making process. In any case, the influence of public information on scientific issues is an extremely important factor to consider in the design of clinical trials in exceptional situations such as a pandemic.

BACKGROUND A platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient–health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy. OBJECTIVE The overall aims of the trial are to customize the platform; assess the system’s ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals. METHODS Patients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires. RESULTS A total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period. CONCLUSIONS ONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved. CLINICALTRIAL ClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724

Background A platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient–health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy. Objective The overall aims of the trial are to customize the platform; assess the system’s ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals. Methods Patients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires. Results A total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period. Conclusions ONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved. Trial Registration ClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724

// Alessandro Passardi 1, * , Emanuela Scarpi 2, * , Luigi Cavanna 3 , Monia Dall’Agata 2 , Davide Tassinari 4 , Silvana Leo 5 , Ilaria Bernardini 6 , Fabio Gelsomino 7 , Stefano Tamberi 8 , Alba A. Brandes 9 , Elena Tenti 10 , Roberto Vespignani 11 , Giovanni L. Frassineti 1 , Dino Amadori 1 , Ugo De Giorgi 1 1 Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy 2 Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola, Italy 3 Medical Oncology Unit, Guglielmo da Saliceto Hospital, Piacenza, Italy 4 Department of Oncology, Infermi Hospital, Rimini, Italy 5 Medical Oncology Unit, Vito Fazzi Hospital, Lecce, Italy 6 Medical Oncology Unit, Ramazzini Hospital, Carpi, Italy 7 Oncology Unit, University Hospital Modena, Modena, Italy 8 Oncology Unit, Degli Infermi Hospital, Faenza, Italy 9 Department of Medical Oncology, Azienda USL, Bellaria Hospital - IRCCS Institute of Neurological Sciences, Bologna, Italy 10 Oncology Pharmacy Laboratory, IRST IRCCS, Meldola, Italy 11 IT Service, IRST IRCCS, Meldola, Italy * These authors have contributed equally to this work Correspondence to: Emanuela Scarpi, e-mail: emanuela.scarpi@irst.emr.it Keywords: metastatic colorectal cancer, bevacizumab, SII NLR PLR, prognosis Received: February 24, 2016 Accepted: April 04, 2016 Published: April 21, 2016 ABSTRACT Background: To investigate the role of pre-treatment inflammatory indexes (II) as predictors of prognosis and treatment efficacy in patients with metastatic colorectal cancer mCRC randomized onto the prospective multicenter randomized ITACa (Italian Trial in Advanced Colorectal Cancer) trial to receive first-line chemotherapy (CT) with or without bevacizumab (Bev). Results: In the overall population, PFS and OS were higher in patients with low SII ( p = .015 and .002, respectively), low NLR ( p = .0001 and

e13072 Background: Bone Metastases (BM) are still the main cause of morbidity and morbility in cancer patients because of their complications defined as skeletal-related events (SREs).SREs reduce pts quality of life and are associated with an increasing in social and health costs. At present, data concerning BM are mainly obtained retrospectively from monocentric experiences. Methods: We performed a multicentre prospective observational study of patients with BM from breast cancer (BC) with at least 6 month (m)'s follow-up who were registered in a prospective BM database (BMDB). Detailed information on patients at first diagnosis of BM was recorded in a custom-built software system, updated every 6 m by participating centres and reviewed by the coordinator centre.All pts have signed an informed consent. Results: Since October 2014,618 pts with BM from solid tumors were enrolled of whom 220 have BC as primitive site with a 6 m follow-up. Median age was 62 y (range 26-86). Median Follow up was 34 m (6-149). At enrolment 109 (50%) had only BM and 109 (50%) pts had concomitant visceral and BM. Median time to first BM was 47 m (range 0-312) in Bone only disease and 78.6 m in pts with visceral bone metastases. Disease Free interval (DFI) was different according to BC molecular subtypes and stage. The univariate hazard ratio (HR) for visceral or bone metastasis was higher in luminal B tumors (1.56, 95% confidence interval [CI]:1.1-2.3) (p = 0.002), basal-like (2.50, 95% CI:1.1-6.0) (p = 0.043), and HER2-enriched tumors (1.37, 95% CI:0.78-2.4) (p = 0.273). DFI for pts with stage I disease at diagnosis of primary BC was longer than that for stage III pts (median 67.2 m, 95%CI:53.1-96.1, vs. 58.1 m, 95%CI:41.9-73.4), with a HR of 1.84 (95% CI:1.1-3.0) (p = 0.015) for the stage III group, and 0.98 (95% C.I.:0.6-1.5) (p = 0.930) for the stage II group. During BM disease, 98 pts had at least 1 SREs . Zoledronate was used in 69.1% and Denosumab in 28.3% of cases. First line treatment was hormone-based (n = 105, 50.7%) chemo-based therapy (n = 80, 38.7%) and chemo+ormono based (n = 20, 9.7%). During follow up progression disease occurred in 167 pts. Median progression-free (mPFS) and overall survival calculated from metastatic disease diagnosis (mOS) were 15.1 m (95%CI 12.6-18.4) and 66.8 m (95%CI 52.1-79.2),respectively. Conclusions: This study presents prospective data about a cohort of BC pts enrolled at the first BM occurrence and followed over the time, extrapolated by the multicentric observational BMDB in order to better understed the clinical history of breast cancer and bone metastases.

Andrea Casadei Gardini,1,* Emanuela Scarpi,2,* Elena Orlandi,3 Davide Tassinari,4 Silvana Leo,5 Ilaria Bernardini,6 Fabio Gelsomino,7 Stefano Tamberi,8 Silvia Ruscelli,1 Roberto Vespignani,9 Sonia Ronconi,10 Giovanni Luca Frassineti,1 Dino Amadori,1 Alessandro Passardi1 1Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy; 2Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola, Italy; 3Medical Oncology Department, Piacenza Hospital, Piacenza, Italy; 4Department of Oncology, City Hospital, Rimini, Italy; 5Medical Oncology Unit, Vito Fazzi Hospital, Lecce, Italy; 6Medical Oncology Unit, Ramazzini Hospital, Carpi, Italy; 7Department of Oncology and Hematology, Division of Oncology, University Hospital Modena, Italy; 8Oncolgy Unit, Degli Infermi Hospital, Faenza, Italy; 9IT Service, IRST IRCCS, Meldola, Italy; 10Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy *These authors contributed equally to this work Background: The aim of this study was to investigate the role of pre-treatment aspartate aminotransferase-lynphocyte ratio (ALRI) as a predictor of prognosis and treatment efficacy in patients with metastatic colorectal cancer (mCRC) enrolled in the prospective multicenter randomized ITACa (Italian Trial in Advanced Colorectal Cancer) trial to receive first-line chemotherapy (CT) + bevacizumab (B) or CT alone. Patients and methods: Patients randomly received CT+B or CT alone as first-line therapy. CT consisted of either FOLFOX4 or FOLFIRI at the clinician’s discretion. Results: Out of the 284 patients enrolled, increased ALRI levels were associated with shorter PFS and OS (p

Background: We assessed the real-life clinical impact of bone health management in patients with breast cancer (BC) receiving adjuvant endocrine therapy at an Italian Osteoncology Center. Methods: Pre- and post-menopausal women undergoing adjuvant endocrine therapy for early-stage BC who came to our institute for their first bone health evaluation from January 2011 to June 2016 were considered in this retrospective observational study. Results: 1125 pre- and post-menopausal early-stage BC patients (209 and 916, respectively) were evaluated. Median age was 61 years (range 26&ndash, 88). In the pre-menopausal group, spinal x-ray revealed that 10 patients (4.7%) had a morphometric vertebral fracture. Higher age (OR: 1.14, 95% CI: 1.01&ndash, 1.29) and bone mineral density (BMD) &le, &minus, 2.5 (OR: 14.45, 95% CI: 1.70&ndash, 122.67) were associated with a higher risk of bone fracture. The overall frequency of bone fracture was 17.6% (n = 161) in post-menopausal patients and a lower risk for bone fractures was associated with tamoxifen or other treatments (OR: 0.25, 95% CI: 0.12&ndash, 0.53), presence of back pain (OR: 1.65, 95% CI: 1.16&ndash, 2.36), lower BMD (OR: 2.09 in patients with T-score &le, 2.5, 95% CI: 1.21&ndash, 3.59) and lower vitamin D levels (OR: 1.57 in patients with &le, 10 ng/mL, 95% CI: 1.05&ndash, 2.34) in univariate analysis. Conclusion: Our findings confirm that bone health management should be an integral part of long-term cancer care.

Background Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. Methods/Design The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle. Discussion The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care. Trial registration ClinicalTrials.gov, NCT02645357

e12055 Background: Bone health evaluation is important for the optimal management of early stage breast cancer (BC) both in post and pre-menopausal setting. Adjuvant endocrine therapy (ET), including luteinizing hormone-releasing hormone (LHRH) analogues with tamoxifen (TAM) and aromatase inhibitors (AI), may affect bone health resulting in a reduction of the bone mineral density (BMD), leading to an increased risk of bone fractures. The objective of this observational study performed at an Italian Osteoncology Center was to evaluate the prevalence of vertebral fractures in pre and post women with BC treated with adjuvant ET. Methods: Data on patients (pts) with early BC were collected from 2011 to 2016 in a single Institution. We investigated the prevalence of vertebral fractures in pre and post pts treated with ET and other potential independent risk factors associated to bone fractures. To evaluate association with bone fractures and clinical factors, univariate logistic models were carried out. P-value of less than 0.05 was considered significant. Results: A total of 1,165 women with early pre and post-menopausal BC were evaluated; for 702 (60.2%) pts treated with ET was available a X-Ray of the spine and they were included in the analysis. The median age was 61 year-old (31-86 y). A total of 124 were pre-menopausal and 578 were post-menopausal pts. Frequency of bone fractures was 17.6% in post-menopausal and, among them, the major risk of bone fractures was associated with AI treatment (OR:4.37, p:0.005); in pre-menopausal pts bone fractures incidence was 6.4% and the major risk was associated to LHRH+AI treatment (OR:2.18, p:0.307). Higher risk of bone fractures was associated with presence of back-pain (OR:1.81, p:0.006), a lower BMD (OR:2.91, p: < 0.001 for pts with BMD≤2.5) and lower level of Vitamin D (OR:2.06, p:0.030 for pts with ≤10) in univariate analysis. Further analysis are ongoing. Conclusions: This Italian experience confirms the importance of bone health evaluation in order to prevent bone fractures in the management of pre and post-menopausal early BC treated with ET.

Introduction Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system. Methods and analysis We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient–doctor communication. Ethics and dissemination Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. Trial registration number ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18.

e13075Background: BM are still the main cause of morbidity and morbility in cancer patients, mostly due to their complications defined as skeletal-related event (SRE). SRE reduce patients’quality o...