Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk

NCT05268783 | Recruiting

• 1 other identifier: Quali-NET
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 7

Brief Summary

Neuroendocrine tumors (NET) are rare tumors that require specific diagnosis and treatment. Therefore, this poses a challenge for clinical practice. Diagnosis and treatment can be optimized when physician specialists and other healthcare providers, across various hospitals, join forces to provide patients the best care. Based on this idea, a hospital network called NETwerk was set up. The following hospitals are part of this network: University Hospital Antwerp, VITAZ, AZ Monica, AZ Voorkempen, AZ Klina, Gasthuiszusters Antwerpen, Ziekenhuis Netwerk Antwerpen and AZ Rivierenland. In this NETwerk, patients with a neuroendocrine tumor or patients suspected with a neuroendocrine tumor are discussed with the specialists and treated.The aim of this study is to map the quality of life of NET patients within NETwerk in order to optimize the quality of care. Throughout the diagnosis, the treatment process and the follow-up, the patient will be asked to fill out three questionnaires (QLQ-C30, QLQ-GI.NET21 and a satisfaction survey). These questionnaires will be filled out every six months at home. Patients will be asked to complete these questionnaires over a period of five years.

Conditions

Quality of Life

Keywords

neuroendocrine neoplasms

Outcome Measures

Primary Outcomes (2)

• Quality of life measurement with QLQ-C30 questionnaire

  Quality of life measurement with QLQ-C30 questionnaire

  5 years

• Quality of life measurement with QLQ-GI.NET21 questionnaire

  Quality of life measurement with QLQ-GI.NET21 questionnaire

  5 years

Secondary Outcomes (1)

• Quality of care measurement with satisfaction survey

  5 years

Study Arms (1)

NEN patients

EXPERIMENTAL

EORTC QLQ-C30, EORTC QLQ-GI.NET21 and satisfaction survey

Procedure: EORTC QLQ-C30; Procedure: EORTC QLQ-GI.NET21; Procedure: Satisfaction survey

Interventions

EORTC QLQ-C30 PROCEDURE

Quality of life questionnaire that has to be completed every 6 months

NEN patients

EORTC QLQ-GI.NET21 PROCEDURE

Quality of life questionnaire that has to be completed every 6 months

NEN patients

Satisfaction survey PROCEDURE

Questionnaire regarding satisfaction of care that has to be completed on Day 1.

NEN patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NEN patient
• years or older
• Patient should appear in Oncobase

You may not qualify if:

• Patients who do not have an email address

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (7)

AZ Klina

Brasschaat, Antwerp, 2930, Belgium

RECRUITING

AZ Monica

Deurne, Antwerp, 2100, Belgium

NOT YET RECRUITING

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

AZ Rivierenland

Rumst, Antwerp, 2840, Belgium

RECRUITING

VITAZ

Sint-Niklaas, East-Flanders, 9100, Belgium

RECRUITING

ZNA

Antwerp, 2020, Belgium

RECRUITING

GZA

Antwerp, 2610, Belgium

RECRUITING

Central Study Contacts

Timon U Vandamme

CONTACT

03821; timon.vandamme@uza.be

Isolde Van der Massen

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 7, 2022
• Study Start: November 5, 2018
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (7)