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

NCT06614647 | Recruiting

• 1 other identifier: RESPONSE
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 9

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

Conditions

Quality of Life; Survivorship; Colorectal Cancer

Keywords

Circulating Tumor DNA; Organ-specific late effects; Biopsychosocial Late effects

Outcome Measures

Primary Outcomes (1)

• Health related Quality of Life (HRQoL)

  The outcome will be evaluated by EORTC QLQ-C30 - Global. The overall difference between the IG and SG will be calculated, with a score difference of 7 or more considered the minimal clinically important difference (MID).

  At 3 and 5 years follow-up.

Secondary Outcomes (25)

• Overall survival (OS)

  At 3 and 5 years follow-up

• Recurrence-free survival (RFS)

  At 3 and 5 years follow-up.

• HRQoL evaluated by EORTC QLQ-C30 for the five functional scales

  At 12 and 36 months.

• HRQoL evaluated by EQ-5D-5L - EUROQOL - 5 Dimensions 5 Levels

  At 12 and 36 months.

• Fear of Cancer Recurrence Inventory score

  At 12 and 36 months.

Other Outcomes (1)

• Comparison of cutting edge ctDNA detection methods in plasma.

  At 3 and 5 years.

Study Arms (2)

Intervention group (IG)

EXPERIMENTAL

Patients with curatively resected stage I or low risk stage II colorectal cancer, residing in Central or North region, Denmark.

Diagnostic Test: Recurrence monitoring with circulating tumor DNA (ctDNA) as a high risk biomarker; Behavioral: Monitoring for late adverse effects with electronic patient reported outcome measures (ePROMs); Behavioral: Systematic treatment of organ-specific late effects and/or biopsychosocial late effects; Behavioral: Digital care-guide for long-term follow-up after cancer treatment

Standard-of-care group (SG)

NO INTERVENTION

Patients with curatively resected stage I or low risk stage II colorectal cancer, residing in South or Capital region, Denmark.

Interventions

Monitoring for late adverse effects with electronic patient reported outcome measures (ePROMs) BEHAVIORAL

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.

Intervention group (IG)

Systematic treatment of organ-specific late effects and/or biopsychosocial late effects BEHAVIORAL

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.

Intervention group (IG)

Digital care-guide for long-term follow-up after cancer treatment BEHAVIORAL

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.

Intervention group (IG)

Recurrence monitoring with circulating tumor DNA (ctDNA) as a high risk biomarker DIAGNOSTIC_TEST

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.

Intervention group (IG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients treated only with local endoscopic resection, e.g.,Transanal Endoscopic microsurgery (TEM).

Sponsors & Collaborators

• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• University of Southern Denmark: collaborator
• Randers Regional Hospital: collaborator
• Viborg Regional Hospital: collaborator
• Gødstrup Hospital: collaborator
• Odense University Hospital: collaborator
• Herlev Hospital: collaborator
• Bispebjerg Hospital: collaborator
• Sygehus Lillebaelt: collaborator
• Svendborg Hospital: collaborator
• University of Aarhus: lead

Study Sites (9)

Gødstrup Hospital

Herning, Central Jutland, 7400, Denmark

RECRUITING

Regional Hospital Randers

Randers, Central Jutland, 8930, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Odense University Hospital

Odense, The Region of Southern Denmark, 5000, Denmark

RECRUITING

Svendborg Sygehus

Svendborg, The Region of Southern Denmark, 5700, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Bispebjerg Hospital

Copenhagen, 2400, Denmark

RECRUITING

Regional Hospital Horsens

Horsens, 8700, Denmark

RECRUITING

Regional Hospital Viborg

Viborg, 8800, Denmark

RECRUITING

Related Publications (26)

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• Region Midtjylland, R. Emento: www.emento.dk (2023).

  BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lene H Iversen, Prof.

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Peter Christensen, Prof.

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Ole Thorlacius-Ussing, Prof.

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Robert Zacchariae, Prof.

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Liza Sopina, Ass.Prof.

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Claus L Andersen, Prof.

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claus L Andersen, Prof.

CONTACT

+45 78455319; cla@clin.au.dk

Mai-Britt W Ørntoft, Ass. Prof.

CONTACT

+45 78432424; mwo@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Group Leader

Model Details: The region of residency determines the allocation to the intervention group or standard-of-care group. Patients in the intervention group will be stage I-II colorectal cancer survivors residing in Central Denmark Region and North Denmark Region. Both regions have fully implemented 'organ-specific late-effects clinics' offering a standardized patient-centered, interdisciplinary, multiorgan approach and have implemented the digital platform that supports the smartphone care guide. Patients in the standard group will be the corresponding patients residing in the remaining Danish Regions, in which similar standardized late effects clinics and the digital care-guide framework are not yet implemented.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: September 26, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (9)