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

Neuroendocrine Tumors Clinical Trial

— FiReNEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05334290
• Other study ID #: FiReNEN
• Status: Recruiting
• Start date: August 6, 2020
• Est. completion date: August 5, 2024

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Stefano Partelli, Professor
• Phone: 0226437697
• Email: partelli.stefano[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 5, 2024
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Financial Stress
• Neuroendocrine Tumors

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Massimo Falconi

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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 COmprehen — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Financial toxicity	Financial toxicity measured by Comprehensive Score for financial toxicity (COST) and out of pockets.	12 months
Primary	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