- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04324502
Mobile Application to Collect PRO Data in NET Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Neuroendocrine tumours (NET) are uncommon cancers with varied presentation. Patients are treated in specialist centres, and may sometimes have up to 4 lines of treatment; with the attendant complications. To date there has been no study capturing precisely patient reported outcomes (PROMs) and changes in QoL post treatment.
We have worked with the national patient charity and support group (Neuroendocrine Tumour Patient Foundation) and UKINETS, to develop a mobile application that will allow patients to capture details of their symptoms, as well as changes to quality of life during and post treatment. The application has been designed as an aide to patients, capturing details of their illness, treatment and interaction with the healthcare team (appointments).
This study aims to assess whether use of mobile app technology is helpful for patients undergoing medical and surgical therapy for neuroendocrine tumours. The trial is non-invasive and allows participants to record daily symptoms and raise alerts whilst they are undergoing different therapies. Health related quality of life during therapy will be assessed at specified times using EORTC validated questionnaires. The study also aims to investigate any difference in clinicians' response to PROMs; and the time taken to institute change, in any.
Participants are able to download the application from their mobile device app store from whichever location they wish, provided that they have regular internet access to download the app. Participants will be asked to provide daily responses pertaining to their health outcomes (PROs) in addition to completing validated quality of life questionnaires (EORTC CLQ - C30 and EORTC GINET21) at regular intervals over a 4 year period, prior to their treatment starting and throughout their treatment (months 0,3,6,12; and 6 monthly thereafter). This data will be stored in a research-specific database of de-identified patient-reported outcomes on quality of life and health.There are added features for participants to enter their medication information and appointments in the outpatient clinic; functionality to set reminders to take their medication; as well as reminders for upcoming hospital visits; and links to email addresses to contact their primary care teams. Clinicians are able to access the data to identify problems and track response to interventions.
The data will be stored in an encrypted format on the secure servers of Ampersand Health Ltd, who will export the data to the Chief Investigator at King's College Hospital at the end of the study.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Raj Srirajaskanthan
- Telefonnummer: 0203 299 3255
- E-mail: r.srirajaskanthan@nhs.net
Studiesteder
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London, Det Forenede Kongerige, SE5 9RS
- Rekruttering
- King's College Hospital
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Kontakt:
- Raj Srirajaskanthan
- Telefonnummer: 02032996044
- E-mail: r.srirajaskanthan@nhs.net
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Histologically confirmed diagnosis of a NET
- Planned treatment for NET
- Able to give informed consent
- Able to understand the language of the questionnaires
- A minimum expected survival of 6 months
- All performance status is acceptable
- 18 years of age or over
Exclusion Criteria:
- Concurrent malignancies for which they are undergoing treatment
- No smartphone / device
- Any physical, psychological or comprehension problems that prevents completion of questionnaires.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Neuroendocrine neoplasms (tumours)
Patients with a diagnosis of neuroendocrine neoplasm who are due to undergo one of the following treatments: chemotherapy, everolimus, sunitinib, somatostatin analogues, peptide receptor targeted therapy, embolization/ ablative therapies or surgery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Reporting compliance
Tidsramme: 4 years
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The primary endpoint is patient reporting compliance, defined as the number of days with any patient report submitted during the course of treatment.
This will be unique to each course of therapy since they have different durations of treatment.
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4 years
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 259461
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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