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

Catholic University (KU) of Leuven

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06914245

S69283

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

TME/PME

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL)

Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)

Diagnostic Test: Electronic bowel diary

Active surveillance

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL)

Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)

Diagnostic Test: Electronic bowel diary