RESPONSE represented at ESCP 2023 at the “New Trials Forum” session
The RESPONSE project was chosen for oral presentation at ESCP 2023
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” were presented by Post Doc and surgeon, Mai-Britt Worm Ørntoft.
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.
