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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Electronic bowel diary
Diagnostic testThis bowel diary will be available on the smartphone in the form of an application.
Faecal Incontinence Quality of Life questionnaire (FIQL)
Diagnostic testThis questionnaire will be available online.
EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)
Diagnostic testThis questionnaire will be available online.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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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