Developing patient-reported outcomes as part of the DETECTION trial
Research type
Research Study
Full title
Developing patient-reported outcomes as part of the DETECTION trial: Views from patients with an early stage melanoma
IRAS ID
277462
Contact name
David French
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 5 months, 16 days
Research summary
Research Summary
A clinical trial called DETECTION (Circulating tumour DNA guidEd Therapy for stage IIB/C mElanoma after surgiCal resection), is examining the use of ctDNA to identify early relapse of melanoma. This intervention is not available on the NHS and the trial is testing whether it can be used to improve outcomes for patients with melanoma.The present application/research is related to the DETECTION Trial.
To improve patient experience of using ctDNA to inform clinical decision making, the present application aims to qualitatively investigate patient acceptability and views on the test and trial. Data will inform the acceptability and use of ctDNA tests in the trial and NHS more broadly.
Patients with Stage 2B/C Melanoma (identified via Salford Royal NHS Foundation Trust) will be approached to take part in a single one-to-one semi-structured interview either at their home, the university or over the telephone. Participants will be asked about their thoughts on ctDNA being used for clinical decision making and their views on the DETECTION trial design and procedures. Interviews will also explore what concerns they would have if they were to be part of the DETECTION trial and receiving ctDNA tests.
The specific objectives for this study are:
(a)To elicit from patients any concerns about the use of the ctDNA test and the testing procedure, using interviews
(b)To refine patient-facing materials, to reduce the likelihood of any concerns identified adversely affecting recruitment, retention or patient experience in the DETECTION trial
(c)To develop appropriate patient reported measures, to be used as an integral element of the trial, to allow any concerns or other issues that patients have with the use of the test or testing procedure to be quantified
Summary of Results
A clinical trial called DETECTION (Circulating tumour DNA guidEd Therapy for stage IIB/C mElanoma after surgiCal resection), is examining the use of ctDNA to identify early relapse of melanoma. This intervention is not available on the NHS and the trial is testing whether it can be used to improve outcomes for patients with melanoma. The present research is related to the DETECTION Trial. To improve patient experience of using ctDNA to inform clinical decision making, the present study aimed to qualitatively investigate patient acceptability and views on the test and trial. Data from this study will inform the acceptability and use of ctDNA tests in the trial and NHS more broadly.Patients with early stage Melanoma (stages 1a-2c) were approached to take part in a single one-to-one semi-structured interview over the telephone. Participants were asked about their thoughts on ctDNA being used for clinical decision making and their views on the DETECTION trial design and procedures. Interviews also explored what concerns they would have if they were to be part of the DETECTION trial and receiving ctDNA tests.
A reflexive thematic analysis was chosen as the analysis procedure. Views from early stage melanoma patients regarding ctDNA monitoring for signs of early relapse and early treatment were grouped into 2 themes and subthemes: (1) ctDNA monitoring would add service value and (2) test results provide opportunity and knowledge. ctDNA monitoring would add service value centres on how early stage follow-up care would be improved by ctDNA monitoring, with participants describing ctDNA monitoring as more reassuring, more “scientific” than skin checks and preferable to scans. Results provide opportunity and knowledge focuses on how ctDNA results are communicated and how patients would react to them. Participants wanted to know when to expect results to manage anxiety, with a positive result seen as an opportunity to receive treatment early. Notification of a negative result was essential to reduce anxiety and knowledge.
Overall, participants were positive about ctDNA monitoring and early treatment for relapse, indicating that patients would welcome extra surveillance as well as trust and be reassured by the test.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
20/LO/0455
Date of REC Opinion
3 Apr 2020
REC opinion
Further Information Favourable Opinion