Clinical trial NCT05334290: Financial Toxicity and Patient-Reported Outcomes in GEP-NEN During Treatment
Official title: Financial Toxicity and Patient-Reported Outcomes in Italian Patients Affected by Gastroenteropancreatic Neuroendocrine Neoplasms (GEP-NEN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroendocrine Tumors
Keywords: GEP-NEN
financial toxicity
Quality of life
Costs
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Financial toxicity
timeFrame: 12 months
measure: Quality of Life (QoL)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
affiliation: San Raffaele Hospital Milan
name: Stefano Partelli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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;3(1):43-53. doi: 10.1200/JGO.2015.002980. eCollection 2017 Feb.
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 COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
citation: 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.