Financial Toxicity and Patient-Reported Outcomes in Italian Patients Affected by Gastroenteropancreatic Neuroendocrine Neoplasms (GEP-NEN)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Massimo Falconi
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Financial toxicity
Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Financial toxicity
Time Frame: 12 months
Financial toxicity measured by Comprehensive Score for financial toxicity (COST) and out of pockets.
Quality of Life (QoL)
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Massimo Falconi
Head od Pancreatic Surgery Unit
IRCCS San Raffaele