Abstract 28P
Background
Circulating tumour DNA (ctDNA) is a prognostic biomarker in patients (pts) with resected colorectal cancer (CRC) and predicts efficacy of adjuvant chemotherapy (ACT). The ongoing UK wide interventional randomised TRACC Part C trial (NCT04050345) is investigating non-inferiority of de-escalation of ctDNA guided versus standard of care ACT in curatively resected CRC. This study aims to identify and explain mechanisms that promote and inhibit implementation of ctDNA use in healthcare in the context of TRACC part C.
Methods
The study is an ongoing mixed methods process evaluation informed by Normalisation Process Theory (NPT). Quantitative and qualitative data collection occurs at 3 timepoints during recruitment to TRACC. Healthcare professionals (HCP) from TRACC participating sites completed the 23 item Normalisation MeAsure Development survey (NoMAD) and participated in interviews. Pts recruited to TRACC were interviewed. The primary endpoint is to inform the development of an implementation strategy for ctDNA use in guiding ACT decision-making in pts with resected CRC in standard practice. Here we report the results of Timepoint 1.
Results
82 HCPs from 33 sites completed NoMAD surveys. 90% were part of the TRACC site research teams and responses came from a wide range of professional roles. HCPs from 10 sites were interviewed. 21 pts from 7 sites were interviewed. Survey responses showed that 81% of HCPs agreed or strongly agreed with ctDNA use having potential value, 71% agreed or strongly agreed that the work could be easily integrated into practice and 67% felt that ctDNA use will become a normal part of practice in the future. For pts clear communication and management of expectations regarding results were of key importance. Altruism and trust in the team were motivations to take part, as well as perceived personal benefit.
Conclusions
Findings from Timepoint 1 were encouraging in terms of HCP and pt acceptance of ctDNA use to guide ACT decision-making. These findings will inform Timepoint 2 data collection and the ongoing development of an implementation strategy for ctDNA use in CRC.
Clinical trial identification
NCT04050345.
Legal entity responsible for the study
Royal Marsden NHS Foundation Trust.
Funding
National Institute for Health Research.
Disclosure
S. Cruickshank: Financial Interests, Personal and Institutional, Advisory Board: BD MDS; Financial Interests, Personal and Institutional, Invited Speaker: Novartis, Pfizer; Financial Interests, Institutional, Research Grant: Gilead; Financial Interests, Personal, Ownership Interest: Eildon Consulting Ltd. I. Chau: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Eli Lilly, MSD, Roche, Merck Serono, AstraZeneca, OncXerna, Astella, Incyte, GSK, Sotio, Daiichi Sankyo, Eisai, Taiho, Seagen, Turning Point Therapeutics, Novartis, Takeda, Elevation Oncology; Financial Interests, Personal, Invited Speaker: Eisai, Eli Lilly, Servier, Roche; Financial Interests, Institutional, Invited Speaker: Cilag-Janssen, Eli Lilly. N. Starling: Financial Interests, Personal, Advisory Board: GSK, Novartis, MSD Oncology, Servier, AstraZeneca, Pfizer, Gilead Sciences, Seagen, Janssen, Takeda, Moderna, BMS; Financial Interests, Personal, Invited Speaker: Eli Lilly, Pierre Fabre, Amgen, Merck Serono, Novartis, MSD Oncology, GSK, Servier, Seagen, BMS, AstraZeneca, Astellas; Financial Interests, Institutional, Research Grant, Sept 2017 (24m) Paid to institution research: Merck; Financial Interests, Institutional, Research Grant, Nov 2017 (48m) -Paid to institution research fund: AstraZeneca; Financial Interests, Institutional, Research Grant, Jan 2018 - Paid to institution research fund: Pfizer; Financial Interests, Institutional, Research Grant, July 2018 (36m) Paid to institution research fund: BMS; Financial Interests, Institutional, Research Grant, June 2022 - Paid to institution research fund: Guardant; Financial Interests, Institutional, Research Grant, August 2023 - Paid to institution research fund: Gilead; Non-Financial Interests, Advisory Role, Ad Board uncompensated: Guardant. D. Cunningham: Financial Interests, Institutional, Research Grant: Clovis, Eli Lilly, 4SC, Bayer, Celgene, Leap, Roche; Financial Interests, Personal and Institutional, Advisory Board: Ovibio. All other authors have declared no conflicts of interest.