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RecruitingNCT05268783Quali-NETUpdated Mar 24, 2022

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

An interventional study of EORTC QLQ-C30 and EORTC QLQ-GI.NET21 in Quality of Life, sponsored by University Hospital, Antwerp. Recruiting at 7 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-24.

Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Nov 2018, registered Feb 2022).
  • Started Nov 2018; still recruiting 7 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Quality of Life

Keywords

  • neuroendocrine neoplasms
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who do not have an email address
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    NEN patients

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

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

Interventions

  • ProcedureEORTC QLQ-C30

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

  • ProcedureEORTC QLQ-GI.NET21

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

  • ProcedureSatisfaction survey

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

06

What researchers measure

Primary outcomes

  1. Quality of life measurement with QLQ-C30 questionnaire

    Quality of life measurement with QLQ-C30 questionnaire

    Time frame: 5 years

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

    Quality of life measurement with QLQ-GI.NET21 questionnaire

    Time frame: 5 years

Secondary outcomes

  1. Quality of care measurement with satisfaction survey

    Quality of care measurement with satisfaction survey

    Time frame: 5 years

07

Study locations

6 of 7 sites recruiting
  • AZ Klina
    Brasschaat, Antwerp 2930, Belgium
    • Wim Demey · Contact
    Recruiting
  • AZ Monica
    Deurne, Antwerp 2100, Belgium
    • Laura Wuyts · Contact
    Not yet recruiting
  • Antwerp University Hospital
    Edegem, Antwerp 2650, Belgium
    • Timon Vandamme · Contact
    Recruiting
  • AZ Rivierenland
    Rumst, Antwerp 2840, Belgium
    • Marijke Ulenaers · Contact
    Recruiting
  • VITAZ
    Sint-Niklaas, East-Flanders 9100, Belgium
    • Willem Lybaert · Contact
    Recruiting
  • ZNA
    Antwerp, 2020, Belgium
    • Frank Van Fraeyenhove · Contact
    Recruiting
  • GZA
    Antwerp, 2610, Belgium
    • Isabelle Maurissen · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05268783
Lead sponsor
University Hospital, Antwerp
Responsible party
Sponsor
First posted
Mar 7, 2022
Start date
Nov 5, 2018
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Mar 24, 2022

Study contacts

Timon U Vandamme
Contact
timon.vandamme@uza.be
03821 ext. 2111
Isolde Van der Massen
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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