NCT05334290

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

3.2 years

First QC Date

March 30, 2022

Last Update Submit

March 10, 2024

Conditions

Neuroendocrine Tumors

Keywords

GEP-NENfinancial toxicityQuality of lifeCosts

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ≥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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28717741RESULT

  • 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.

    PMID: 27716900RESULT

  • 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.

    PMID: 22422138RESULT

MeSH Terms

Conditions

Neuroendocrine TumorsFinancial Stress

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Stefano Partelli, Professor

    San Raffaele Hospital Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Partelli, Professor

CONTACT

0226437697partelli.stefano@hsr.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head od Pancreatic Surgery Unit

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 19, 2022

Study Start

August 6, 2020

Primary Completion

October 5, 2023

Study Completion

August 5, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

IT(1)