Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Tre… (NCT06914245) | Clinical Trial Compass
RecruitingNot Applicable
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)
Belgium150 participantsStarted 2025-04-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bowel symptoms after rectal cancer treatment
Timeframe: 12 months
2
The evaluation of Quality of Life (QoL) related to bowel symptoms after rectal cancer treatment
Timeframe: 12 months
3
The evaluation of overall Quality of Life (QoL) after rectal cancer treatment