Quality of LifeQuali-NETNCT05268783
Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk
A study testing EORTC QLQ-C30, EORTC QLQ-GI.NET21 and Satisfaction survey in people with Quality of Life, run by University Hospital, Antwerp at 7 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- EORTC QLQ-C30, EORTC QLQ-GI.NET21 and Satisfaction survey
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 7 sitesBelgium
- Study dates
- 5 Nov 2018to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NEN patient
- 18 years or older
- Patient should appear in Oncobase
Who cannot join
- Patients who do not have an email address
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Isolde Van der Massen contact
7 sites in 1 country
Belgium7 sites, 7 recruiting
- Recruiting
ZNA
Antwerp, 2020
Frank Van Fraeyenhove
- Recruiting
GZA
Antwerp, 2610
Isabelle Maurissen
- Recruiting
AZ Klina
Brasschaat, Antwerp, 2930
Wim Demey
- Not yet recruiting
AZ Monica
Deurne, Antwerp, 2100
Laura Wuyts
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Timon Vandamme
- Recruiting
AZ Rivierenland
Rumst, Antwerp, 2840
Marijke Ulenaers
- Recruiting
VITAZ
Sint-Niklaas, East-Flanders, 9100
Willem Lybaert
About this study
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.
- Conditions
- Quality of Life
- Being tested
- EORTC QLQ-C30, EORTC QLQ-GI.NET21, Satisfaction survey
- Keywords
- neuroendocrine neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ-C30Procedure or surgery
Quality of life questionnaire that has to be completed every 6 months
EORTC QLQ-GI.NET21Procedure or surgery
Quality of life questionnaire that has to be completed every 6 months
Satisfaction surveyProcedure or surgery
Questionnaire regarding satisfaction of care that has to be completed on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| NEN patients | Experimental | EORTC QLQ-C30, EORTC QLQ-GI.NET21 and satisfaction survey Receives: Procedure: EORTC QLQ-C30; Procedure: EORTC QLQ-GI.NET21; Procedure: Satisfaction survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measurement with QLQ-C30 questionnaire
Quality of life measurement with QLQ-C30 questionnaire
Measured: 5 years
Quality of life measurement with QLQ-GI.NET21 questionnaire
Quality of life measurement with QLQ-GI.NET21 questionnaire
Measured: 5 years
Secondary outcomes (1)
Quality of care measurement with satisfaction survey
Quality of care measurement with satisfaction survey
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start5 Nov 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268783
- Sponsor's protocol ID
- Quali-NET
- Acronym
- Quali-NET
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk
- ClinicalTrials.gov ID
- NCT05268783
- Acronym / sponsor ID
- Quali-NET / Quali-NET
- Conditions
- Quality of Life
- Keywords
- neuroendocrine neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEN patients | Experimental | Procedure: EORTC QLQ-C30, Procedure: EORTC QLQ-GI.NET21, Procedure: Satisfaction surveyEORTC QLQ-C30, EORTC QLQ-GI.NET21 and satisfaction survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NEN patient
- 18 years or older
- Patient should appear in Oncobase
Key exclusion criteria (1 listed)
- Patients who do not have an email address
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EORTC QLQ-C30Quality of life questionnaire that has to be completed every 6 months | Procedure or surgery | NEN patients |
| EORTC QLQ-GI.NET21Quality of life questionnaire that has to be completed every 6 months | Procedure or surgery | NEN patients |
| Satisfaction surveyQuestionnaire regarding satisfaction of care that has to be completed on Day 1. | Procedure or surgery | NEN patients |
Primary outcome
Quality of life measurement with QLQ-C30 questionnaire
Time frame: 5 years
Quality of life measurement with QLQ-C30 questionnaire
Quality of life measurement with QLQ-GI.NET21 questionnaire
Time frame: 5 years
Quality of life measurement with QLQ-GI.NET21 questionnaire
1 secondary outcome
Quality of care measurement with satisfaction survey
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isolde Van der Massen contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EORTC QLQ-C30, EORTC QLQ-GI.NET21 and Satisfaction survey in people with Quality of Life, run by University Hospital, Antwerp at 7 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timon U Vandamme (03821 ext. 2111, timon.vandamme@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measurement with QLQ-C30 questionnaire (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.