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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer 12 month post-surgery or post-stoma closure. These insights are crucial in developing an effective care approach, as they assist us in determining when specific evaluations should be conducted and which treatments should be applied at different stages.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Inge Geraerts, PhD
inge.geraerts@kuleuven.be
+3216329120
Backup
Liesbet Lauwereins, Msc.
liesbet.lauwereins@kuleuven.be
+3216379147
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2027-06
Participants
Target number of participants: 150
Treatments
Experimental: Contributing factors
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants scheduled for rectal surgery will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (prior to surgery, and at 1, 6, and 12 months post-rectal surgery or post-stoma closure).
Related Therapeutic Areas
Sponsors
Leads: KU Leuven
Collaborators: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov