Digital follow-up care for colorectal cancer survivors

RESPONSE: Colorectal Cancer Survivors' Follow-up Care - Now Digital and Need-based: A National Interventional Effectiveness Trial for Stage I and II Patients

This study is testing a new digital follow-up care program for colorectal cancer survivors to see if it can better support their individual needs and improve their quality of life after treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Aarhus (Academic / other)
• Locations: 9 sites (Herning, Central Jutland and 8 other locations)
• Trial ID: NCT06614647 on ClinicalTrials.gov

What this trial studies

This project is testing a new, digitally managed follow-up program for colorectal cancer survivors, specifically focusing on stage I and low-risk stage II patients. The program aims to address individual patient needs by monitoring not only for cancer recurrence but also for late adverse effects and psychological distress. It utilizes circulating tumor DNA (ctDNA) as a biomarker for recurrence monitoring and incorporates electronic patient-reported outcome measures (ePROMs) to systematically treat late effects. The goal is to enhance the quality of life for survivors by providing tailored support rather than a one-size-fits-all approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been treated for stage I and low-risk stage II colorectal cancer with curative intent.

Not a fit: Patients who have undergone only local endoscopic resection or those unable to comply with the digital platform may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the quality of life for colorectal cancer survivors by addressing their specific needs and concerns.

How similar studies have performed: While there is ongoing research in personalized follow-up care for cancer survivors, this specific approach utilizing digital tools and ctDNA monitoring is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients treated for stage I and low risk stage II colorectal cancer with curative intend.
2. Age 18 years or older.
3. Understands spoken and written Danish language.
4. Able to use digital care-guide as smartphone application.
5. The patient is also included in DANISH.MRD part 1.

Exclusion Criteria:

1. Patients who are unlikely to comply with the protocol, unable to return for subsequent visits and/or otherwise considered by the PIs to be unlikely to complete the study.
2. Patients who are not able or willing to adhere to the digital platform.
3. Patients treated only with local endoscopic resection, e.g.,Transanal Endoscopic microsurgery (TEM).

Where this trial is running

Herning, Central Jutland and 8 other locations

• Gødstrup Hospital — Herning, Central Jutland, Denmark (Recruiting)
• Regional Hospital Randers — Randers, Central Jutland, Denmark (Recruiting)
• Aalborg University Hospital — Aalborg, North Denmark, Denmark (Recruiting)
• Odense University Hospital — Odense, The Region of Southern Denmark, Denmark (Recruiting)
• Svendborg Sygehus — Svendborg, The Region of Southern Denmark, Denmark (Recruiting)
• Aarhus University Hospital — Aarhus, Denmark (Recruiting)
• Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
• Regional Hospital Horsens — Horsens, Denmark (Recruiting)
• Regional Hospital Viborg — Viborg, Denmark (Recruiting)

Study contacts

• Principal investigator: Lene H Iversen, Prof. — University of Aarhus
• Study coordinator: Claus L Andersen, Prof.

Conditions Colorectal Cancer; Quality of Life; Survivorship; Circulating Tumor DNA; Organ-specific late effects; Biopsychosocial Late effects