Personalized care pathways for bowel symptoms after rectal cancer treatment

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

This project will test whether using an electronic bowel diary and quality-of-life questionnaires can identify treatable causes of ongoing bowel problems in people treated for rectal cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: KU Leuven (other)
• Drugs / interventions: radiation
• Locations: 1 site (Leuven, Vlaams-Brabant)
• Trial ID: NCT06914245 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls adults treated for rectal cancer with total or partial mesorectal excision or managed with a watch-and-wait approach. Participants use an electronic bowel diary and complete standardized questionnaires (FIQL and EQ-5D-5L), with outcomes measured 12 months after surgery or stoma closure, or 12 months after completion of neoadjuvant therapy for surveillance patients. The study links symptom patterns and questionnaire scores to clinical and treatment factors to identify contributors to persistent bowel dysfunction. Results are intended to inform when and which evaluations and treatments should be offered as part of a personalized care pathway.

Who should consider this trial

Good fit: Adults (≥18) who read and speak Dutch, provide informed consent, and are scheduled for total or partial mesorectal excision or enrolled in a watch-and-wait protocol for rectal cancer are ideal candidates.

Not a fit: Patients who had other procedures (e.g., Hartmann, abdominoperineal excision), preexisting fecal incontinence, neurological bowel disorders, prior pelvic radiation or rectal surgery for non-cancer reasons, or a permanent stoma are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could enable tailored care plans that reduce bowel symptoms and improve quality of life after rectal cancer.

How similar studies have performed: Symptom diaries and quality-of-life measures have been used to describe Low Anterior Resection Syndrome, but translating these data into fully personalized care pathways is a relatively new approach with limited prior proof of widespread effectiveness.

Eligibility criteria

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.

Where this trial is running

Leuven, Vlaams-Brabant

• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)

Study contacts

• Principal investigator: Inge Geraerts, PhD — KU Leuven
• Study coordinator: Inge Geraerts, PhD

Conditions: Rectal Cancer, LARS - Low Anterior Resection Syndrome, Active Surveillance, Bowel diary, Quality of Life, Care pathway