Financial Toxicity and Patient-Reported Outcomes in GEP-NEN During Treatment

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Financial Toxicity and Patient-Reported Outcomes in Italian Patients Affected by Gastroenteropancreatic Neuroendocrine Neoplasms (GEP-NEN)

Conditions
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Neuroendocrine Tumors

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age New diagnosis of gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) Patients who are candidates for surgical and/or medical treatment [including somatostatin analogues (SAA), peptide recector radionuclide therapy (PRRT), target therapies (everolimus or sunitinib) and chemotherapy]; Signed informed consent Exclusion Criteria: Age < 18 years Patients diagnosed with GEP-NEN who are candidates for a surveillance management. Patients diagnosed with GEP-NEN who are candidates for best supportive care and/or have a life expectancy < 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Financial toxicity | Financial toxicity measured by Comprehensive Score for financial toxicity (COST) and out of pockets. | 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) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GEP-NEN, financial toxicity, Quality of life, Costs