Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable) (Treatable)

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

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 negatively affects various aspects of bowel function and patients' quality of life. These bowel symptoms often remain prevalent, even 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, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine when specific evaluations should be conducted and which treatments should be applied at different stages.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; LARS - Low Anterior Resection Syndrome; Active Surveillance
• Intervention / Treatment: Diagnostic test: Electronic bowel diary; Diagnostic test: Faecal Incontinence Quality of Life questionnaire (FIQL); Diagnostic test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inge Geraerts, PhD; Phone Number: +3216329120; Email: inge.geraerts@kuleuven.be
• Study Contact Backup: Name: Liesbet Lauwereins, MSc.; Phone Number: +3216379147; Email: liesbet.lauwereins@kuleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Liesbet Lauwereins, MSc.; Phone Number: +3216379147; Email: liesbet.lauwereins@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TME/PME; 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).	Diagnostic test: Electronic bowel diary; This bowel diary will be available on the smartphone in the form of an application.; Diagnostic test: Faecal Incontinence Quality of Life questionnaire (FIQL); This questionnaire will be available online.; Diagnostic test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L); This questionnaire will be available online.
Experimental: Active surveillance; To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants in active surveillance will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (at baseline and at 1, 6, and 12 months after completion of neoadjuvant therapy).	Diagnostic test: Electronic bowel diary; This bowel diary will be available on the smartphone in the form of an application.; Diagnostic test: Faecal Incontinence Quality of Life questionnaire (FIQL); This questionnaire will be available online.; Diagnostic test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L); This questionnaire will be available online.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of Quality of Life (QoL) related to bowel symptoms after rectal cancer treatment	Faecal Incontinence Quality of Life questionnaire (FIQL) will be used for the evaluation of QoL related to faecal incontinence problems. The FIQL is a reliable and valid 41-item questionnaire, resulting in 4 subscales: Lifestyle, Coping/behavior, Depression/Self Perception and Embarrassment. The Scales ranges from 1 to 5, with a 1 indicating a lower functional status of quality of life. This questionnaire is also validated in Dutch.	12 months
The evaluation of overall Quality of Life (QoL) after rectal cancer treatment	EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) will be used to assess overall quality of life (QoL). The EQ-5D-5L is a reliable and valid 6-item questionnaire, consisting of two parts: the social perspective and the individual perspective of one's own health. In the social perspective, the health state is converted into a value set with a score ranging from 0 to 1, where 0 represents being dead and 1 represents full health. The individual perspective assesses the respondent's own perception of their health, with a score ranging from 0 to 100. This questionnaire is validated in Dutch and widely used to measure general health-related quality of life.	12 months
Bowel symptoms after rectal cancer treatment	To ensure that patients can report all their bowel symptoms where they suffer from, a valid, reliable, user-friendly, and easy-to-interpret electronic bowel diary has been developed in another research project for which approval has already been obtained from the Ethical Committee of the University Hospitals Leuven (S68746). This electronic bowel diary will be used to map out all bowel complaints.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Defecation functions will be assessed with the Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument (MSKCC-BFI). The MSKCC-BFI is a broad bowel specific questionnaire (18 items), resulting in three subscales, four single items and one total score for bowel function.	12 months
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	Defecation functions will be assessed with the LARS score. The LARS score is a short questionnaire, consisting of 5 items, stratifying patients into no, minor or major LARS. This questionnaire has been validated in Dutch.	12 months
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	Defecation functions will be assessed with the Patient Assessment of Constipation-Symptoms questionnaire (PAC-SYM). The PAC-SYM is a validated constipation-specific questionnaire of 12 items that reflect stool, rectal and abdominal symptoms. Patients report the severity of each symptom on a Likert scale from 0 (absent) to 4 (very severe). This questionnaire has been validated in Dutch.	12 months
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	Information concerning the patient age will be derived from the medical file.	pre-operatively, prior to the surgical intervention for rectal cancer
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	Information concerning the gender of the patient will be derived from the medical file.	pre-operatively, prior to the surgical intervention for rectal cancer
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	Information concerning diabetes will be derived from the medical file.	pre-operatively, prior to the surgical intervention for rectal cancer
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	Information concerning smoking history (current, former, never) will be queried.	pre-operatively, prior to the surgical intervention for rectal cancer
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	Information regarding the patient's BMI will be collected pre-operatively.	pre-operatively, prior to the surgical intervention for rectal cancer
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	Depression will be measured using the Patient Health Questionnaire (PHQ-9), a 9-item validated Dutch questionnaire with scores ranging from 0 to 27. Higher scores indicate more severe depression, classifying patients into mild, moderate, moderately severe, or severe depression.	12 months
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	Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item validated Dutch questionnaire with a score range of 0 to 21. Higher scores reflect greater anxiety severity, categorizing patients into mild, moderate, or severe anxiety.	12 months
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	Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC), a 10-item questionnaire with scores ranging from 0 to 40, where higher scores indicate greater resilience. The scale was translated into Dutch using the forward-backward translation technique to ensure accuracy.	12 months
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	The assessment of optimal physiotherapy care for bowel symptoms during and after RC treatment will be defined based on available scientific evidence, guidelines and clinical expertise of the promotors of this project. Through a self-developed questionnaire, patients will be questioned which care they received in order to estimate by the research team whether they received no/suboptimal/optimal PT care.	at 6 months post-surgery or post-stoma closure
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	TNM-stage, tumor height, neoadjuvant therapy, stoma prior to surgery, date rectal cancer surgery, approach rectal resection, surgery technique, reconstruction technique, type of anastomosis, Rullier classification, inferior mesenteric artery ligation, inferior mesenteric vein ligation, type of stoma, date stoma closure, adjuvant therapy, post-operative complication, anastomotic leakage classification, Clavien-Dindo classification will be derived from the medical file.	At 1 month post-surgery or post-stoma closure

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Universitair Ziekenhuis Brussel; AZ Delta; General Hospital Groeninge; UZ Leuven, Leuven, Belgium; Meander MC, Amersfoort, the Netherlands; Heilig Hart Ziekenhuis Lier; AZ Oostende; Ziekenhuis aan de Stroom; AZORG
• Investigators: Principal Investigator: Inge Geraerts, PhD, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Care pathway; Quality of Life (QoL); Bowel diary
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Low Anterior Resection Syndrome; Rectal Neoplasms
• Other Study ID Numbers: S69283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No