Development of an e-diary for bowel symptoms in rectal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create a validated bowel diary to assess and evaluate bowel symptoms in patients who have undergone treatment for rectal cancer. Given the high prevalence of Low Anterior Resection Syndrome (LARS) and its significant impact on quality of life, the e-diary will help capture the full range of bowel-related issues that patients face post-treatment. The study will involve rectal cancer patients who can read and converse in Dutch, and it will focus on gathering comprehensive data to improve patient care pathways.

Why it matters

Who can join: the full rules

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 after rectal surgery for rectal cancer or under Watch and Wait protocol (also referred to as active surveillance).

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.

Where it's running

• UZ Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Inge Geraerts, PhD — KU Leuven
• Study coordinator: Inge Geraerts, PhD
• Email: inge.geraerts@kuleuven.be
• Phone: +3216329120

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Rectal cancer registry to track real-world treatments and outcomes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.