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Trial record 34 of 54 for:    somatostatin analogues | Neuroendocrine Tumors

Mobile Application to Collect PRO Data in NET Patients

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ClinicalTrials.gov Identifier: NCT04324502
Recruitment Status : Not yet recruiting
First Posted : March 27, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
Ampersand Health Ltd
Neuroendocrine Cancer UK
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Brief Summary:
Observational trial to assess the feasibility of monitoring patient reporting symptoms via mobile devices

Condition or disease
Neuroendocrine Neoplasms (Tumours)

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mobile Application to Collect PRO Data in NET Patients
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Reporting compliance [ Time Frame: 4 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324502


Contacts
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Contact: Raj Srirajaskanthan 0203 299 3255 r.srirajaskanthan@nhs.net

Sponsors and Collaborators
King's College Hospital NHS Trust
Ampersand Health Ltd
Neuroendocrine Cancer UK
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT04324502    
Other Study ID Numbers: 259461
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue