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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Behavioral, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Bispebjerg Hospital
RECRUITING
Copenhagen
Herlev Hospital
NOT_YET_RECRUITING
Herlev
Gødstrup Hospital
RECRUITING
Herning
Regional Hospital Horsens
RECRUITING
Horsens
Odense University Hospital
RECRUITING
Odense
Regional Hospital Randers
RECRUITING
Randers
Svendborg Sygehus
RECRUITING
Svendborg
Regional Hospital Viborg
RECRUITING
Viborg
Contact Information
Primary
Claus L Andersen, Prof.
cla@clin.au.dk
+45 78455319
Backup
Mai-Britt W Ørntoft, Ass. Prof.
mwo@clin.au.dk
+45 78432424
Time Frame
Start Date: 2024-09-15
Estimated Completion Date: 2030-02-01
Participants
Target number of participants: 400
Treatments
Experimental: Intervention group (IG)
Patients with curatively resected stage I or low risk stage II colorectal cancer, residing in Central or North region, Denmark.
No_intervention: Standard-of-care group (SG)
Patients with curatively resected stage I or low risk stage II colorectal cancer, residing in South or Capital region, Denmark.
Related Therapeutic Areas
Sponsors
Collaborators: Bispebjerg Hospital, University of Southern Denmark, Viborg Regional Hospital, Gødstrup Hospital, Odense University Hospital, Svendborg Hospital, Randers Regional Hospital, Sygehus Lillebaelt, Aalborg University Hospital, Herlev Hospital, Aarhus University Hospital
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov