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

NCT06914245 | Recruiting

• 1 other identifier: S69283
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rectal Cancer; LARS - Low Anterior Resection Syndrome; Active Surveillance

Keywords

Bowel diary; Quality of Life (QoL); Care pathway

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

TME/PME

EXPERIMENTAL

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; Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL); Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)

Active surveillance

EXPERIMENTAL

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; Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL); Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)

Interventions

Faecal Incontinence Quality of Life questionnaire (FIQL) DIAGNOSTIC_TEST

This questionnaire will be available online.

Active surveillance; TME/PME

Electronic bowel diary DIAGNOSTIC_TEST

This bowel diary will be available on the smartphone in the form of an application.

Active surveillance; TME/PME

EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) DIAGNOSTIC_TEST

This questionnaire will be available online.

Active surveillance; TME/PME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• AZ Delta: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• Ziekenhuis aan de Stroom: collaborator
• AZ Oostende: collaborator
• General Hospital Groeninge: collaborator
• Heilig Hart Ziekenhuis Lier: collaborator
• Meander MC, Amersfoort, the Netherlands: collaborator
• AZORG: collaborator
• UZ Leuven, Leuven, Belgium: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Inge Geraerts, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inge Geraerts, PhD

CONTACT

+3216329120; inge.geraerts@kuleuven.be

Liesbet Lauwereins, Msc.

CONTACT

+3216379147; liesbet.lauwereins@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

BE (1)