Mobile Application to Collect PRO Data in NET Patients

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

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Raj Srirajaskanthan; Phone Number: 0203 299 3255; Email: r.srirajaskanthan@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital
    • Contact: Raj Srirajaskanthan; Phone Number: 02032996044; Email: r.srirajaskanthan@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reporting compliance	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.	4 years

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: Ampersand Health Ltd; Neuroendocrine Cancer UK

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: 259461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No