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

Not Applicable

Not yet recruiting

• Conditions: Rectal Cancer; LARS - Low Anterior Resection Syndrome

• Registration Number: NCT06914245
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Study Start: 2025-04
• Study First Posted: 2025-04-06
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2027-03
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Bowel symptoms after rectal cancer treatment	12 months	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 is being developed in another research project for which approval has already been obtained from the Ethical Committee of the University Hospitals Leuven (S68746). Once this electronic bowel diary is developed, the investigators will use it to map out all bowel complaints.
The evaluation of Quality of Life (QoL) related to bowel symptoms after rectal cancer treatment	12 months	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.
The evaluation of overall Quality of Life (QoL) after rectal cancer treatment	12 months	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.

Secondary Outcome Measures

Name	Time	Method
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	pre-operatively, prior to the surgical intervention for rectal cancer	Information concerning the patient age will be derived from the medical file.
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	pre-operatively, prior to the surgical intervention for rectal cancer	Information concerning the gender of the patient will be derived from the medical file.
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	pre-operatively, prior to the surgical intervention for rectal cancer	Information concerning diabetes will be derived from the medical file.
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	pre-operatively, prior to the surgical intervention for rectal cancer	Information concerning smoking history (current, former, never) will be queried.
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	pre-operatively, prior to the surgical intervention for rectal cancer	Information regarding the patient's BMI will be collected pre-operatively.
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	12 months	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.
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	12 months	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.
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	12 months	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.
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	12 months	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.
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	12 months	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.
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	12 months	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.
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	at 6 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.
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	At 1 month 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.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium