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

Recruiting

• Conditions: Neuroendocrine Tumors

• Registration Number: NCT05334290
• Lead Sponsor: Massimo Falconi

Brief Summary

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

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

Study Timeline

• Study Start: 2020-08-06
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-16
• Study First Posted: 2022-04-19
• Primary Completion: 2023-10-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-12
• Study Completion: 2024-08-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Financial toxicity	12 months	Financial toxicity measured by Comprehensive Score for financial toxicity (COST) and out of pockets.
Quality of Life (QoL)	12 months	Evaluate the QoL of patients affected by GEP-NEN, as measured by the Questionnaires assessing the QoL of Cancer Patients (QLQ-C30)

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy