Development of an e-diary for bowel symptoms in rectal cancer patients
Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine
This study is trying to create an easy-to-use online diary for rectal cancer patients to track their bowel symptoms after treatment and see how it affects their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06274190 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with a rectal tumor and can communicate in Dutch.
Not a fit: Patients who have undergone surgeries other than low anterior resection or have pre-existing bowel function issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this e-diary could enhance the management of bowel symptoms and improve the quality of life for rectal cancer patients.
How similar studies have performed: While the approach of using an e-diary for symptom tracking is innovative, similar studies have shown promise in improving patient outcomes in other cancer-related contexts.
Eligibility criteria
Show full inclusion / exclusion 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 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 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
- Email: inge.geraerts@kuleuven.be
- Phone: +3216329120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.