Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)

NCT ID: NCT06914245

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2028-12-31

Brief Summary

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Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection combined with chemoradiotherapy. However, this treatment negatively affects various aspects of bowel function and patients' quality of life. These bowel symptoms often remain prevalent, even 12 months after RC treatment.

The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine when specific evaluations should be conducted and which treatments should be applied at different stages.

Detailed Description

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Conditions

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Rectal Cancer LARS - Low Anterior Resection Syndrome Active Surveillance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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TME/PME

To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants scheduled for rectal surgery will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (prior to surgery, and at 1, 6, and 12 months post-rectal surgery or post-stoma closure).

Group Type EXPERIMENTAL

Electronic bowel diary

Intervention Type DIAGNOSTIC_TEST

This bowel diary will be available on the smartphone in the form of an application.

Faecal Incontinence Quality of Life questionnaire (FIQL)

Intervention Type DIAGNOSTIC_TEST

This questionnaire will be available online.

EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)

Intervention Type DIAGNOSTIC_TEST

This questionnaire will be available online.

Active surveillance

To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants in active surveillance will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (at baseline and at 1, 6, and 12 months after completion of neoadjuvant therapy).

Group Type EXPERIMENTAL

Electronic bowel diary

Intervention Type DIAGNOSTIC_TEST

This bowel diary will be available on the smartphone in the form of an application.

Faecal Incontinence Quality of Life questionnaire (FIQL)

Intervention Type DIAGNOSTIC_TEST

This questionnaire will be available online.

EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)

Intervention Type DIAGNOSTIC_TEST

This questionnaire will be available online.

Interventions

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Electronic bowel diary

This bowel diary will be available on the smartphone in the form of an application.

Intervention Type DIAGNOSTIC_TEST

Faecal Incontinence Quality of Life questionnaire (FIQL)

This questionnaire will be available online.

Intervention Type DIAGNOSTIC_TEST

EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)

This questionnaire will be available online.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
* At least 18 years of age at the time of signing the Informed Consent Form (ICF).
* Proficient in reading, comprehending, and conversing in Dutch.
* Patients scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer.

Exclusion Criteria

* The participant has undergone a different type of surgery, including a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection.
* Experienced fecal incontinence prior to undergoing surgery.
* Are affected by neurological disorders affecting bowel function.
* Already underwent previous pelvic radiation or rectal surgery for non-cancer reasons.
* Has a permanent stoma.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Delta

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role collaborator

Ziekenhuis aan de Stroom

OTHER

Sponsor Role collaborator

AZ Oostende

UNKNOWN

Sponsor Role collaborator

General Hospital Groeninge

OTHER

Sponsor Role collaborator

Heilig Hart Ziekenhuis Lier

UNKNOWN

Sponsor Role collaborator

Meander MC, Amersfoort, the Netherlands

UNKNOWN

Sponsor Role collaborator

AZORG

UNKNOWN

Sponsor Role collaborator

UZ Leuven, Leuven, Belgium

UNKNOWN

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Inge Geraerts

Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inge Geraerts, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Inge Geraerts, PhD

Role: CONTACT

+3216329120

Liesbet Lauwereins, Msc.

Role: CONTACT

+3216379147

Facility Contacts

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Liesbet Lauwereins, Msc.

Role: primary

+3216379147

Other Identifiers

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S69283

Identifier Type: -

Identifier Source: org_study_id

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