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

Summary

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.

Conditions

• Rectal Cancer
• LARS - Low Anterior Resection Syndrome
• Active Surveillance

Interventions

DIAGNOSTIC_TEST

Electronic bowel diary

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

DIAGNOSTIC_TEST

Faecal Incontinence Quality of Life questionnaire (FIQL)

This questionnaire will be available online.

DIAGNOSTIC_TEST

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

This questionnaire will be available online.

Sponsors & Collaborators

• AZ Delta

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Ziekenhuis aan de Stroom

  collaborator OTHER

• AZ Oostende

  collaborator UNKNOWN

• General Hospital Groeninge

  collaborator OTHER

• Heilig Hart Ziekenhuis Lier

  collaborator UNKNOWN

• Meander MC, Amersfoort, the Netherlands

  collaborator UNKNOWN

• AZORG

  collaborator UNKNOWN

• UZ Leuven, Leuven, Belgium

  collaborator UNKNOWN

• KU Leuven

  lead OTHER

Principal Investigators

• Inge Geraerts, PhD · KU Leuven

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-28

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Belgium

Study Locations