The Impact of Melanoma and Drug Treatment in the Real World

Completed

• Conditions: Melanoma

• Registration Number: NCT03379454
• Lead Sponsor: Vitaccess Ltd

Brief Summary

An observational, non-interventional registry study to collect real-world data from people living with melanoma and its treatment, which will be available to researchers to further the knowledge of melanoma and improve patient care.

Detailed Description

The registry uses Vitaccess' digital real-world evidence platform, and has been developed in collaboration with the patient advocacy group Melanoma UK.

Eligible participants install a study app on their smartphone or tablet. Researchers access aggregated, anonymised data via a cloud-based research portal. The platform provides benefits to participants, which it is hoped will encourage persistence with data submission; these include options to upload electronic documents such as scans, and access an online melanoma community.

The aggregated data are available in close to real time via "dashboards" and can be analysed according to a number of pre-set criteria (e.g. disease stage, age, geographic location).

State-of-the-art technologies and security policies are used in the platform to ensure industry-standard data storage and privacy for all users. Participants' personally identifiable information will remain confidential at all times, and researchers will not be able to identify individuals.

Study Timeline

• Study Start: 2017-10-25
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-20
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 819

Inclusion Criteria

• adults with melanoma of any stage, resident in the UK with National Health Service (NHS) or Community Health Index (CHI) number, aged 18 and over, current or previous diagnosis of melanoma, willing to use their own smartphone or tablet.

Exclusion Criteria

• no specific exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life (HRQL), general	Monthly throughout 4 year study duration	EQ-5D-5L

Secondary Outcome Measures

Name	Time	Method
Health-Related Quality of Life (HRQL), symptoms	Monthly throughout 4 year study duration	PRO-CTCAE
Health-Related Quality of Life (HRQL), oncology	Monthly throughout 4 year study duration	QLQ-C30

Trial Locations

Locations (1)

Vitaccess Ltd; 🇬🇧 Oxford, United Kingdom