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

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

September 15, 2024

Primary Completion Date

March 15, 2028

Study Completion Date

February 1, 2030

Conditions
Colorectal CancerQuality of LifeSurvivorship
Interventions
DIAGNOSTIC_TEST

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."

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Trial Locations (10)

2400

RECRUITING

Bispebjerg Hospital, Copenhagen

2730

NOT_YET_RECRUITING

Herlev Hospital, Herlev

5000

RECRUITING

Odense University Hospital, Odense

5700

RECRUITING

Svendborg Sygehus, Svendborg

7400

RECRUITING

Gødstrup Hospital, Herning

8000

RECRUITING

Aarhus University Hospital, Aarhus

8700

RECRUITING

Regional Hospital Horsens, Horsens

8800

RECRUITING

Regional Hospital Viborg, Viborg

8930

RECRUITING

Regional Hospital Randers, Randers

9000

RECRUITING

Aalborg University Hospital, Aalborg

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Aalborg University Hospital

OTHER

collaborator

University of Southern Denmark

OTHER

collaborator

Randers Regional Hospital

OTHER

collaborator

Viborg Regional Hospital

OTHER

collaborator

Gødstrup Hospital

OTHER

collaborator

Odense University Hospital

OTHER

collaborator

Herlev Hospital

OTHER

collaborator

Bispebjerg Hospital

OTHER

collaborator

Sygehus Lillebaelt

OTHER

collaborator

Svendborg Hospital

OTHER

lead

University of Aarhus

OTHER