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
About this trial
This is an interventional treatment trial for Quality of Life focused on measuring neuroendocrine neoplasms
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
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
NCT ID
NCT05268783
First Posted
February 24, 2022
Last Updated
March 8, 2022
Sponsor
University Hospital, Antwerp
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
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