Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06914245

Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine

Led by KU Leuven · Updated on 2026-01-23

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

K

KU Leuven

Lead Sponsor

A

AZ Delta

Collaborating Sponsor

AI-Summary

What this Trial Is About

Rectal cancer is a common type of cancer affecting both women and men, with about 40% of cases located in the rectum. Standard treatment usually involves surgery combined with chemoradiotherapy, but this can cause lasting bowel function problems and reduce quality of life. This research aims to understand the factors that contribute to ongoing bowel symptoms and how these affect patients' quality of life one year after surgery, stoma closure, or completion of neoadjuvant therapy in those under active surveillance. Participants include patients undergoing rectal surgery or managed with active surveillance. They will use an electronic bowel diary app on their phones and complete online questionnaires at multiple times: before surgery and at 1, 6, and 12 months afterward for surgical patients, or at baseline and 1, 6, and 12 months after neoadjuvant therapy for those in active surveillance. The study evaluates bowel symptoms and their impact on quality of life using several validated tools. During the study, participants will track bowel function and quality of life through diaries and questionnaires at set intervals. Researchers will measure bowel symptoms, quality of life related to bowel function, and overall quality of life at 12 months. They will also assess how factors like age, gender, diabetes, smoking, body mass index, depression, and anxiety might predict persistent bowel issues. The study runs until December 2028 and is led by KU Leuven.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary written informed consent obtained before screening
  • At least 18 years old at the time of consent
  • Proficient in reading, understanding, and speaking Dutch
  • Scheduled for Total Mesorectal Excision (TME), Partial Mesorectal Excision (PME), or following a watch-and-wait protocol for rectal cancer
Not Eligible

You will not qualify if you...

  • Underwent other surgeries such as Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection
  • Had fecal incontinence before surgery
  • Have neurological disorders affecting bowel function
  • Previously received pelvic radiation or rectal surgery for non-cancer reasons
  • Have a permanent stoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Active Surveillance

Duration - 12 months

Participants in active surveillance complete an electronic bowel diary on their mobile phones and fill out online questionnaires at multiple time points to track bowel symptoms and quality of life.

4 assessment time points: baseline, 1 month, 6 months, and 12 months

Treatment and Monitoring

Duration - 12 months

Participants scheduled for rectal surgery complete an electronic bowel diary on their mobile phones and fill out online questionnaires prior to surgery and at multiple time points following surgery or stoma closure to monitor bowel symptoms and quality of life.

4 assessment time points: prior to surgery, and at 1 month, 6 months, and 12 months post-surgery or post-stoma closure

Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

I

Inge Geraerts, PhD

L

Liesbet Lauwereins, Msc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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