Actively Recruiting
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
Eligibility Criteria
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.
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
Your Study Journey
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
Duration - 7 consecutive days
Participants will use the electronic bowel diary application to record their bowel symptoms.
1 week of daily diary entries
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
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
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
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