Clinical trial · Interventional
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary
Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. In recent years, organ-preserving strategies such as Watch and Wait have become more widely implemented. Although these patients avoid surgical morbidity, emerging evidence shows that neoadjuvant radiotherapy alone can also cause substantial and persistent bowel dysfunction. Therefore, the study population was expanded to include patients managed with a Watch and Wait strategy in addition to those undergoing TME/PME.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| LARS - Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bowel e-diary | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- Pre-Delphi patient focus group
- description
- During this focus group, we aim to achieve various goals: * To gain insight into the bowel symptoms and the consequences patients experienced after treating rectal cancer * To understand the expectations of the patients regarding an electronic bowel diary * To determine whether the questions/items derived from the literature study for the bowel diary are clear and understandable for the patients * To explore other relevant questions/items that should be added to the bowel diary We will include 8-12 patients in this focus group.
- type
- NO_INTERVENTION
- label
- Delphi survey
- description
- In this Delphi survey, a multidisciplinary group of experts and patients will score each item of the long list on a 1-9-point Likert scale from 'Not relevant' (1) to 'Essential' (9) for inclusion in the bowel diary. Finally, a patient consultation meeting and a consensus meeting will be held for the participants who completed the Delphi survey. We will recruit 10-18 Delphi panelists per area of expertise. These panelists are experts with international expert recognition in treating bowel symptoms in the following health care categories (abdominal surgeons, digestive/radiation oncologists, specialized pelvic floor muscle physiotherapists, nursing specialists). In addition, we will include one group comprising 10-18 patients in the Delphi survey, ensuring a comprehensive and holistic perspective on treating bowel symptoms across various healthcare categories.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 after rectal surgery for rectal cancer or under Watch and Wait protocol (also referred to as active surveillance). 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.
References
Publications (0)
Data not yet available