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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05334290

Acronym

FiReNEN

Enrollment

400

Registered

2022-04-19

Start date

2020-08-06

Completion date

2024-08-05

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

GEP-NEN, financial toxicity, Quality of life, Costs

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Italy

Contacts

Primary ContactStefano Partelli, Professor

partelli.stefano@hsr.it0226437697

Outcome results