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RESPONSE: Colorectal Cancer Survivors' Follow-up Care - Now Digital and Need-based
Sponsor: University of Aarhus
Summary
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.
Official title: RESPONSE: Colorectal Cancer Survivors' Follow-up Care - Now Digital and Need-based: A National Interventional Effectiveness Trial for Stage I and II Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-09-15
Completion Date
2030-02-01
Last Updated
2026-02-06
Healthy Volunteers
No
Interventions
Recurrence monitoring with circulating tumor DNA (ctDNA) as a high risk biomarker
IG patients will receive the following intervention at 3, 12, 24, and 36 months post-surgery: 1\) Recurrence risk stratification by ctDNA analysis of blood samples: a) Only if ctDNA becomes positive, will imaging be performed. b) If ctDNA is positive, but recurrent disease is not detected by imaging or clinical and endoscopic evaluation, the patient will be referred back to intensified ctDNA measurements repeated every 4 months until either ctDNA becomes negative or recurrence is confirmed by subsequent imaging.
Monitoring for late adverse effects with electronic patient reported outcome measures (ePROMs)
2\) Collection and analyses of ePROMs to identify whether patients suffer from organ-specific late effects or biopsychosocial late effects and monitor of health related quality of life and the impact of late adverse effects hereon.
Systematic treatment of organ-specific late effects and/or biopsychosocial late effects
3\) When needed, standardized treatment for organ-specific late effects according to newly published national guidelines at specialized centers. Further, online cognitive behavioral therapy is offered to patients suffering from severe biopsychosocial late effects.
Digital care-guide for long-term follow-up after cancer treatment
Use of a digital care-guide from study inclusion to guide the patient trough the follow-up program, in the form of a personalized smart phone app.
Locations (10)
Herlev Hospital
Herlev, Capital Region of Denmark, Denmark
Gødstrup Hospital
Herning, Central Jutland, Denmark
Regional Hospital Randers
Randers, Central Jutland, Denmark
Aalborg University Hospital
Aalborg, North Denmark, Denmark
Odense University Hospital
Odense, The Region of Southern Denmark, Denmark
Svendborg Sygehus
Svendborg, The Region of Southern Denmark, Denmark
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Regional Hospital Horsens
Horsens, Denmark
Regional Hospital Viborg
Viborg, Denmark