search
Back to results

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

Primary Purpose

Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
EORTC QLQ-C30
EORTC QLQ-GI.NET21
Satisfaction survey
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring neuroendocrine neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who do not have an email address

Sites / Locations

  • AZ KlinaRecruiting
  • AZ Monica
  • Antwerp University HospitalRecruiting
  • AZ RivierenlandRecruiting
  • VITAZRecruiting
  • ZNARecruiting
  • GZARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEN patients

Arm Description

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

Outcomes

Primary Outcome Measures

Quality of life measurement with QLQ-C30 questionnaire
Quality of life measurement with QLQ-C30 questionnaire
Quality of life measurement with QLQ-GI.NET21 questionnaire
Quality of life measurement with QLQ-GI.NET21 questionnaire

Secondary Outcome Measures

Quality of care measurement with satisfaction survey
Quality of care measurement with satisfaction survey

Full Information

First Posted
February 24, 2022
Last Updated
March 8, 2022
Sponsor
University Hospital, Antwerp
search

1. Study Identification

Unique Protocol Identification Number
NCT05268783
Brief Title
Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk
Acronym
Quali-NET
Official Title
Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life
Keywords
neuroendocrine neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NEN patients
Arm Type
Experimental
Arm Description
EORTC QLQ-C30, EORTC QLQ-GI.NET21 and satisfaction survey
Intervention Type
Procedure
Intervention Name(s)
EORTC QLQ-C30
Intervention Description
Quality of life questionnaire that has to be completed every 6 months
Intervention Type
Procedure
Intervention Name(s)
EORTC QLQ-GI.NET21
Intervention Description
Quality of life questionnaire that has to be completed every 6 months
Intervention Type
Procedure
Intervention Name(s)
Satisfaction survey
Intervention Description
Questionnaire regarding satisfaction of care that has to be completed on Day 1.
Primary Outcome Measure Information:
Title
Quality of life measurement with QLQ-C30 questionnaire
Description
Quality of life measurement with QLQ-C30 questionnaire
Time Frame
5 years
Title
Quality of life measurement with QLQ-GI.NET21 questionnaire
Description
Quality of life measurement with QLQ-GI.NET21 questionnaire
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Quality of care measurement with satisfaction survey
Description
Quality of care measurement with satisfaction survey
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NEN patient 18 years or older Patient should appear in Oncobase Exclusion Criteria: Patients who do not have an email address
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timon U Vandamme
Phone
03821
Ext
2111
Email
timon.vandamme@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Isolde Van der Massen
Facility Information:
Facility Name
AZ Klina
City
Brasschaat
State/Province
Antwerp
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Demey
Facility Name
AZ Monica
City
Deurne
State/Province
Antwerp
ZIP/Postal Code
2100
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Wuyts
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timon Vandamme
Facility Name
AZ Rivierenland
City
Rumst
State/Province
Antwerp
ZIP/Postal Code
2840
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marijke Ulenaers
Facility Name
VITAZ
City
Sint-Niklaas
State/Province
East-Flanders
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willem Lybaert
Facility Name
ZNA
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Van Fraeyenhove
Facility Name
GZA
City
Antwerp
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Maurissen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs