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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Electronic bowel diary

    Diagnostic test

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

  • Faecal Incontinence Quality of Life questionnaire (FIQL)

    Diagnostic test

    This questionnaire will be available online.

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

    Diagnostic test

    This questionnaire will be available online.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: TME/PMEExperimental treatment 3 interventions
Group B: Active surveillanceExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

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.

Time frame
pre-operatively, prior to the surgical intervention for rectal cancer

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KU Leuven

Lead sponsor

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