- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05268783
Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk (Quali-NET)
March 8, 2022 updated by: University Hospital, Antwerp
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Timon U Vandamme
- Phone Number: 2111 03821
- Email: timon.vandamme@uza.be
Study Contact Backup
- Name: Isolde Van der Massen
Study Locations
-
-
-
Antwerp, Belgium, 2020
- Recruiting
- ZNA
-
Contact:
- Frank Van Fraeyenhove
-
Antwerp, Belgium, 2610
- Recruiting
- GZA
-
Contact:
- Isabelle Maurissen
-
-
Antwerp
-
Brasschaat, Antwerp, Belgium, 2930
- Recruiting
- AZ Klina
-
Deurne, Antwerp, Belgium, 2100
- Not yet recruiting
- AZ Monica
-
Contact:
- Laura Wuyts
-
Edegem, Antwerp, Belgium, 2650
- Recruiting
- Antwerp University Hospital
-
Rumst, Antwerp, Belgium, 2840
- Recruiting
- AZ Rivierenland
-
-
East-Flanders
-
Sint-Niklaas, East-Flanders, Belgium, 9100
- Recruiting
- VITAZ
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- NEN patient
- 18 years or older
- Patient should appear in Oncobase
Exclusion Criteria:
- Patients who do not have an email address
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NEN patients
EORTC QLQ-C30, EORTC QLQ-GI.NET21 and satisfaction survey
|
Quality of life questionnaire that has to be completed every 6 months
Quality of life questionnaire that has to be completed every 6 months
Questionnaire regarding satisfaction of care that has to be completed on Day 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life measurement with QLQ-C30 questionnaire
Time Frame: 5 years
|
Quality of life measurement with QLQ-C30 questionnaire
|
5 years
|
Quality of life measurement with QLQ-GI.NET21 questionnaire
Time Frame: 5 years
|
Quality of life measurement with QLQ-GI.NET21 questionnaire
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of care measurement with satisfaction survey
Time Frame: 5 years
|
Quality of care measurement with satisfaction survey
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 5, 2018
Primary Completion (ANTICIPATED)
December 31, 2029
Study Completion (ANTICIPATED)
December 31, 2029
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
February 24, 2022
First Posted (ACTUAL)
March 7, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 24, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Quali-NET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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