Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05334290

Recruiting

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

Observational

Phase not listed

IRCCS Ospedale San Raffaele

Sponsor: Massimo Falconi

Last Updated: March 12, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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).

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Treatment Category

Required Mutations

None

Trial Started

August 6, 2020

Last Updated by Sponsor

March 12, 2024

Estimated Completion

October 5, 2023

Contact Study

Name:Stefano Partelli, Professor

Email:partelli.stefano@hsr.it

Phone:0226437697

Eligibility

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.

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Design Details

AllocationN/A

Intervention ModelN/A

MaskingN/A

Number to Enroll400

Arms & Interventions

Arms

Interventions

No interventions available.

Outcome Measures

Primary Outcome Measures

Financial toxicity12 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)

Secondary Outcome Measures

None

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Trial Sites

This study has 1 trial site

IRCCS Ospedale San Raffaele

Milano, Milano, IT

Name:Stefano Partelli, Professor

Email:partelli.stefano@hsr.it

Phone:0226437697

Recruiting

Milano, Milano, 20132 IT

IRCCS Ospedale San Raffaele

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