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Taking people in DenmarkNo phase

New digital follow-up program for colorectal cancer survivors compared with standard care

Tests a digital, needs-based follow-up program in adults treated for early colorectal cancer.

Plain-language title generated from the registry record
Registry title: RESPONSE: Colorectal Cancer Survivors' Follow-up Care - Now Digital and Need-based

Key facts

Where
Aalborg, Aarhus, Copenhagen, Herning, Horsens, Odense, Randers, Svendborg, and Viborg, DenmarkSee the 9 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults treated for early-stage colorectal cancer with the aim of removing all of the disease. It tests a digital, need-based follow-up program.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Stage I or low-risk stage II colorectal cancer, treated with the aim of removing all of the disease.
Earlier treatment
Must not have been treated only with local endoscopic resection, for example Transanal Endoscopic microsurgery (TEM).

Main reasons for not taking part

  • Unlikely to follow the study plan or to return for later visits
  • Not able or not willing to use the digital platform
  • Treated only with local endoscopic resection, for example TEM

Read by machine on 9 November 2026.

Where in Denmark

  • Aalborg University HospitalAalborg, DenmarkTaking people
  • Aarhus University HospitalAarhus, DenmarkTaking people
  • Bispebjerg HospitalCopenhagen, DenmarkTaking people
  • Gødstrup HospitalHerning, DenmarkTaking people
  • Regional Hospital HorsensHorsens, DenmarkTaking people
  • Odense University HospitalOdense, DenmarkTaking people
  • Regional Hospital RandersRanders, DenmarkTaking people
  • Svendborg SygehusSvendborg, DenmarkTaking people
  • Regional Hospital ViborgViborg, DenmarkTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
University of Aarhus
Trial code
NCT06614647
Record updated
4 May 2026
Original description
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.Read full original descriptionShow less

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

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, patient-centered follow-up program that focuses on individual patient needs, including fear of cancer recurrence, psychological well-being, management of late adverse effects, and recurrence surveillance. This new program will be compared to the current standard of care in a national network of 11 colorectal cancer surgical centers in four of five Danish regions.

Patients in the intervention group will receive the following:

1. Risk-stratified circulating tumor DNA (ctDNA) guided recurrence surveillance. 2. Late adverse effects monitoring with electronic patient-reported outcome measures, which are validated questionnaires that can identify and qualify late adverse effects. 3. Systematic treatment for organ-specific and/or biopsychosocial late adverse effects. 4. A digital care guide, to support the patient trajectory through the follow-up program, as a smartphone app.

Patients in the standard group will receive standard-of-care follow-up.

The primary study endpoint will be the difference in health-related quality of life between the intervention and standard group. Secondary outcomes include e.g., comparison of health-related costs, differences in fear of cancer recurrence, recurrence-free survival, and patient satisfaction.

The investigators expect the new follow-up program to be better than the standard-of-care program in terms of the primary endpoint - quality of life - without compromising recurrence detection, and without increasing costs.

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

Exclusion: Patients treated only with local endoscopic resection, e.g.,Transanal Endoscopic microsurgery (TEM); 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; Patients who are not able or willing to adhere to the digital platform.

ClinicalTrials.gov NCT06614647