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

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.

Conditions

• Colorectal Cancer
• Quality of Life
• Survivorship

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.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Svendborg Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Lene H Iversen, Prof. · University of Aarhus

• Peter Christensen, Prof. · Aarhus University Hospital

• Ole Thorlacius-Ussing, Prof. · Aalborg University Hospital

• Robert Zacchariae, Prof. · Aarhus University Hospital

• Liza Sopina, Ass.Prof. · University of Southern Denmark

• Claus L Andersen, Prof. · University of Aarhus

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-15

Primary Completion

2028-03-15

Completion

2030-02-01

Countries

• Denmark

Study Locations