The RESPONSE study was represented at the DCCC ctDNA center’s annual meeting 2023
The RESPONSE project was chosen for oral presentation at the DCCC ctDNA center’s annual meeting in November.
One of ACROBATIC’s affiliated projects “RESPONSE: Colorectal cancer survivors’ follow-up care – now digital and need-based. A national interventional effectiveness trial for stage I and II patients” was presented by Post Doc Sidsel Christy Lindgaard.
Read more about the project below:
Background: Due to colorectal cancer (CRC) screening, the number of early stage I-II CRC survivors has increased. Their risk of recurrence is low (5-10%), whereas their risk of moderate to severe ‘late adverse effects’ (LAEs) after treatment is much higher (30-50%), including poor quality of life (QoL) and organ-specific sequelae. These concerns are not addressed in the current ‘one-size-fits-all’ follow-up program, which solely is focused on recurrence detection. Thus, for 90-95% of stage I-II CRC survivors today’s program is irrelevant.
Objectives and research questions: To balance the low recurrence risk against the need for support due to ‘LAEs, we aim to develop an improved follow-up program and compare it to standard-of-care. We hypothesize that the program will improve CRC survivors’ health-related QoL without compromising recurrence-free survival (RFS).
Methods: The study is a national multicentre two-armed intervention effectiveness trial. The intervention follow-up program includes 1) circulating tumor DNA guided recurrence risk surveillance; 2) identification of physical and psychological LAEs with digital assessment of Patient Reported Outcomes (PROs); 3) treatment of LAEs; and 4) a smartphone app to guide the patient through the program. Controls will receive standard-of-care. All stage I-II CRC patients >18 years, who have received curative surgery, are eligible. The primary outcome is difference in EORTC-QLQ-C30 scores 3-years post-surgery. Secondary outcomes include differences in fear-of-cancer-recurrence, severity of LAEs, RFS, and health care costs. A mean EORCT-QLQ-C30 global score of 61 is expected at follow-up. To detect a clinically meaningful difference of 7 points with 80% power, a 5% significance level, and an expected drop-out rate of 10%, 189 patients need be included in each group.
Time frame and funding: Inclusion period: 01-11-23 to 31-10-24, 3 years follow-up. Funding is expected complete in the spring 2024.
