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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Neuroendocrine Tumors

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Stefano Partelli, Professor; Phone Number: 0226437697; Email: partelli.stefano@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • Irccs Ospedale San Raffaele
    • Contact: Stefano Partelli, Professor; Phone Number: 0226437697; Email: partelli.stefano@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massimo Falconi
• Investigators: Principal Investigator: Stefano Partelli, Professor, San Raffaele Hospital Milan

Publications and helpful links

General Publications

• Singh S, Granberg D, Wolin E, Warner R, Sissons M, Kolarova T, Goldstein G, Pavel M, Oberg K, Leyden J. Patient-Reported Burden of a Neuroendocrine Tumor (NET) Diagnosis: Results From the First Global Survey of Patients With NETs. J Glob Oncol. 2016 Jun 8;3(1):43-53. doi: 10.1200/JGO.2015.002980. eCollection 2017 Feb.
• de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
• Beaumont JL, Cella D, Phan AT, Choi S, Liu Z, Yao JC. Comparison of health-related quality of life in patients with neuroendocrine tumors with quality of life in the general US population. Pancreas. 2012 Apr;41(3):461-6. doi: 10.1097/MPA.0b013e3182328045.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2020
• Primary Completion (Actual): October 5, 2023
• Study Completion (Estimated): August 5, 2024

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Costs; financial toxicity; GEP-NEN
• Additional Relevant MeSH Terms: Behavioral Symptoms; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Stress, Psychological; Neuroendocrine Tumors; Financial Stress
• Other Study ID Numbers: FiReNEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No