An observational study in Neuroendocrine Tumors, sponsored by Massimo Falconi. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Massimo Falconi · Observational
The aim of this study is to evaluate the financial toxicity reported by Italian patients affected by GEP-NEN during the first year of treatment after diagnosis and its correlations with patient-reported outcomes (PROs) and quality of life (QoL).
Gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) are rare tumours whose incidence has increased during the years. However, referral centers specialized in diagnosis and treatment of these diseases are few. So, patients may be forced to travel long distances in order to reach a disease specialized center (ENETS certification) to plan the correct management and receive the better treatment. On the other hand, patients could research different clinical consulting by several medical specialists without clear indication. Moreover, today also advanced disease allows the patients a good prognosis with long survival. The resulting emotional and psychological burden may contribute to the worse quality of life. Therefore, patients with GEP-NEN have a deal with the financial consequences related to the diagnosis and treatment of their disease including out of pocket costs, loss of income and caregiver burden. Financial toxicity, defined as subjective financial concerns of cancer and objective financial consequences, has been investigated in this study in Italian patients affected by GEP-NEN
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's planned enrollment of 400 is above the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Massimo Falconi is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
This study enrolls individuals (>18 years) with a new diagnosis of GEP-NEN who are candidates for surgical and/or medical treatment, in Italian Centers. Are excluded from this study patients candidates for a surveillance management and, on the opposite side, with life expectancy \< 6 months or candidates for best supportive care.
Exclusion Criteria:
Financial toxicity
Financial toxicity measured by Comprehensive Score for financial toxicity (COST) and out of pockets.
Time frame: 12 months
Quality of Life (QoL)
Evaluate the QoL of patients affected by GEP-NEN, as measured by the Questionnaires assessing the QoL of Cancer Patients (QLQ-C30)
Time frame: 12 months
Plan to share: Undecided
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Massimo Falconi