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

Quality of Life Clinical Trial

— Quali-NET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268783
• Other study ID #: Quali-NET
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2022
• Source: University Hospital, Antwerp
• Contact: Timon U Vandamme
• Phone: 03821
• Email: timon.vandamme[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• NEN patient

• 18 years or older

• Patient should appear in Oncobase

Exclusion Criteria:

• Patients who do not have an email address

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Tumors
• Quality of Life

Intervention

Procedure:
• EORTC QLQ-C30
Quality of life questionnaire that has to be completed every 6 months
• EORTC QLQ-GI.NET21
Quality of life questionnaire that has to be completed every 6 months
• Satisfaction survey
Questionnaire regarding satisfaction of care that has to be completed on Day 1.

Locations

Country	Name	City	State
Belgium	GZA	Antwerp
Belgium	ZNA	Antwerp
Belgium	AZ Klina	Brasschaat	Antwerp
Belgium	AZ Monica	Deurne	Antwerp
Belgium	Antwerp University Hospital	Edegem	Antwerp
Belgium	AZ Rivierenland	Rumst	Antwerp
Belgium	VITAZ	Sint-Niklaas	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measurement with QLQ-C30 questionnaire	Quality of life measurement with QLQ-C30 questionnaire	5 years
Primary	Quality of life measurement with QLQ-GI.NET21 questionnaire	Quality of life measurement with QLQ-GI.NET21 questionnaire	5 years
Secondary	Quality of care measurement with satisfaction survey	Quality of care measurement with satisfaction survey	5 years