Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06274190

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

Led by KU Leuven · Updated on 2026-04-15

158

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

K

KU Leuven

Lead Sponsor

U

Universitaire Ziekenhuizen KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

Rectal cancer is a common form of colorectal cancer affecting both women and men, with about 40% of cases located in the rectum. The standard treatment typically involves low anterior resection combined with chemoradiotherapy, but this can lead to persistent bowel problems that impact quality of life. Recently, organ-preserving approaches like the Watch and Wait strategy have become more common, though radiotherapy alone may still cause lasting bowel dysfunction. This study aims to develop and validate a comprehensive electronic bowel diary to better diagnose and evaluate all bowel symptoms experienced by these patients. The study includes several phases such as patient focus groups, expert and patient Delphi surveys, and usability testing of the bowel e-diary application available on smartphones. Patients who have undergone rectal cancer surgery or are managed with the Watch and Wait approach will use the e-diary for seven consecutive days across two distinct periods. The study will assess content validity, usability, reliability, and responsiveness of the diary to capture bowel symptoms accurately. Participants will engage in interviews, complete questionnaires, and use the e-diary to record bowel symptoms over defined periods. Researchers will measure the diary's clarity, user-friendliness, and effectiveness using tools like the System Usability Scale. The study will also explore the types and severity of bowel symptoms in patients following different treatment paths. The total study duration for these assessments is 12 months, during which patient feedback and expert input will help refine the bowel diary for broader clinical use.

CONDITIONS

Brief Title

Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

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.
  • Able to read, understand, and speak Dutch.
  • Patients who had rectal surgery for rectal cancer or are under a Watch and Wait protocol.
Not Eligible

You will not qualify if you...

  • Had other types of surgery such as Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection.
  • Experienced fecal incontinence before surgery.
  • Have neurological disorders affecting bowel function.
  • Previously had pelvic radiation or rectal surgery for non-cancer reasons.

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 or remote) for consent and eligibility assessment

Use of the E-diary

Duration - 7 consecutive days

Participants will use the electronic bowel diary application to record their bowel symptoms.

1 week of daily diary entries

Repeated E-diary Assessment

Duration - Two 7-day periods spaced apart within 12 months

Participants who had rectal surgery or are in the Watch and Wait protocol will complete the e-diary during two separate 7-day periods to assess bowel symptoms and the diary's validity.

2 separate 7-day diary usage periods

Participant Feedback and Evaluation

Duration - Concurrent with e-diary usage periods

Participants will provide feedback on the usability of the e-diary through conversations and the System Usability Scale after using it for 7 consecutive days.

1 feedback visit after diary use

Long-term Monitoring

Duration - Up to 12 months

Participants are observed over a 12-month period to evaluate bowel symptoms and the effectiveness of the e-diary in capturing these symptoms accurately.

Periodic assessments during the study duration

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

6

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