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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05334290
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massimo Falconi
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stefano Partelli, Professor
Principal Investigator Affiliation	San Raffaele Hospital Milan
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumors

Additional Details

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

Contact a Trial Team

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International Sites

IRCCS Ospedale San Raffaele, Milan, Italy

Status

Recruiting

Address

IRCCS Ospedale San Raffaele

Milan, , 20132

Site Contact

Stefano Partelli, Professor

[email protected]

0226437697

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