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RESPONSE: Colorectal Cancer Survivors' Follow-up Care - Now Digital and Need-based

RecruitingNAAges 18 Years - anyAllUniversity of Aarhus
NCT06614647 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Over the last decades, the 3-year recurrence rates for patients with stage I and II colorectal cancer have decreased to just 5% and 12%. The follow-up program offered to stage I and low-risk stage II patients has not changed accordingly and is still focused solely on recurrence detection. Moreover, it is a one-size-fits-all program, i.e. most of the follow-up resources are spent on non-recurrence patients who do not benefit. Up to 50% of cancer survivors suffer from reduced quality of life related to fear of cancer recurrence, treatment-related psychological distress, and/or severe late adverse effects of a biopsychosocial and/or organ-specific origin. Today many of these symptoms can be treated effectively. However, no systematic program aimed at monitoring and addressing the symptoms has been implemented yet. The current project is testing a newly developed, digitally managed, patien

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📋 Eligibility rules (as published)
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).
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What it tests

  • Recurrence monitoring with circulating tumor DNA (ctDNA) as a high risk biomarker
  • Monitoring for late adverse effects with electronic patient reported outcome measures (ePROMs)
  • Systematic treatment of organ-specific late effects and/or biopsychosocial late effects
  • Digital care-guide for long-term follow-up after cancer treatment
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Where

9 sites
Gødstrup Hospital
Herning, Denmark
Regional Hospital Randers
Randers, Denmark
Aalborg University Hospital
Aalborg, Denmark
Odense University Hospital
Odense, Denmark
Svendborg Sygehus
Svendborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Regional Hospital Horsens
Horsens, Denmark

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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