Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

Trial Title: Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

NCT ID: NCT06274190

Condition: Rectal Cancer
LARS - Low Anterior Resection Syndrome

Conditions: Official terms:
Rectal Neoplasms
Low Anterior Resection Syndrome

Conditions: Keywords:
Bowel diary
Quality of Life (QoL)
Care pathway

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: bowel e-diary
Description: This bowel diary will be available on the smartphone in the form of an application.
Arm group label: Psychometric properties of e-diary
Arm group label: Usability of e-diary

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. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms.

Detailed description: Colorectal cancer is the 2nd and 3rd most common cancer in women and men, respectively and represents approximately 13% of all new cancer diagnoses, with 40% of cases specifically situated in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, given the improved oncological results, functional outcomes, such as bowel symptoms, become more and more important. Approximately 60-90% of RC patients are affected with a wide range of new onset bowel symptoms (incontinence for flatus or feces (solid, liquid), frequent bowel movements, urgency, clustering of defecation and evacuation problems) immediately after rectal treatment. The combination of these specific bowel symptoms and their impact on quality of life (QoL) has been summarized in an international consensus definition and is referred to as the Low Anterior Resection Syndrome (LARS). Major LARS has an important impact on QoL and has major health economic consequences. This is attributable to its high prevalence after RC treatment, the chronic nature of symptoms and the limited evidence of available therapeutic options. This context leads to repetitive medical consultations, additional technical examinations which are often not very useful and need for prolonged medical treatment (multiple drug regimens), with often limited therapeutic gain. Furthermore, there is a lack of a comprehensive scoring system to identify the different aspects of LARS, leading to inadequate diagnostics and follow-up of symptoms. Based on these considerations, there is a clear need for a comprehensive scoring system for identification of the different aspects of LARS and monitoring of therapeutic treatment.

Criteria for 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 diagnosed with a rectal tumour based on a pathology report. 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UZ Leuven

Address:
City: Leuven
Zip: 3000
Country: Belgium

Status: Recruiting

Contact:
Last name: Liesbet Lauwereins, Msc.

Phone: 016379147
Email: liesbet.lauwereins@kuleuven.be

Start date: April 29, 2024

Completion date: March 2026

Lead sponsor:
Agency: KU Leuven
Agency class: Other

Collaborator:
Agency: Universitaire Ziekenhuizen KU Leuven
Agency class: Other

Source: KU Leuven

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06274190