Clinical trial NCT06914245: Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)
Official title: Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Cancer
LARS - Low Anterior Resection Syndrome
Keywords: Bowel diary
Quality of Life (QoL)
Care pathway
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2025-04-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 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 surgery, previous pelvic radiation or rectal surgery for non-cancer reasons.
* Has a permanent stoma.

Primary outcomes:
measure: Bowel symptoms after rectal cancer treatment
timeFrame: 12 months
measure: The evaluation of Quality of Life (QoL) related to bowel symptoms after rectal cancer treatment
timeFrame: 12 months
measure: The evaluation of overall Quality of Life (QoL) after rectal cancer treatment
timeFrame: 12 months
Secondary outcomes:
measure: The predictive value of 'defecation functions' measured with the MSKCC-BFI for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: 12 months
measure: The predictive value of 'defecation functions' measured with the LARS score for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: 12 months
measure: The predictive value of 'defecation functions' measured with the PAC-SYM for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: 12 months
measure: The predictive value of 'baseline age' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: pre-operatively, prior to the surgical intervention for rectal cancer
measure: The predictive value of 'gender' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: pre-operatively, prior to the surgical intervention for rectal cancer
measure: The predictive value of 'diabetes' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: pre-operatively, prior to the surgical intervention for rectal cancer
measure: The predictive value of 'smoking history' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: pre-operatively, prior to the surgical intervention for rectal cancer
measure: The predictive value of 'BMI' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: pre-operatively, prior to the surgical intervention for rectal cancer
measure: The predictive value of 'depression' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: 12 months
measure: The predictive value of 'anxiety' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: 12 months
measure: The predictive value of 'resilience' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: 12 months
measure: The predictive value of 'Optimal physiotherapy care' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: at 6 months post-surgery or post-stoma closure
measure: The predictive value of 'Treatment-related factors' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
timeFrame: At 1 month post-surgery or post-stoma closure
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Inge Geraerts, PhD
role: PRINCIPAL_INVESTIGATOR
References: