Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Inge Geraerts, PhD
inge.geraerts@kuleuven.be
+3216329120
Backup
Liesbet Lauwereins, MSc.
liesbet.lauwereins@kuleuven.be
+3216379147
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2026-03
Participants
Target number of participants: 118
Treatments
No_intervention: Pre-Delphi patient focus group
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.
No_intervention: Delphi survey
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.
No_intervention: Post-Delphi patient focus group
During this focus group, our objective is to ensure that both the questions and answers are meaningful.~We will include 8-12 patients in this focus group.
Experimental: Usability of e-diary
The participants will be asked to use the newly developed electronic bowel diary for 7 consecutive days.~To evaluate the usability of the e-diary, a group of 10 patients will participate in the assessment using the System Usability Scale (SUS).~Furthermore we will have conversations with these patients regarding the use of the application: complexity, need for additional support, coherence of the application, user-friendliness, and the need for prior knowledge.
Experimental: Psychometric properties of e-diary
To evaluate the validity of the e-diary, encompassing test-retest reliability, construct validity and responsiveness, participants will be instructed to use the e-diary for two separate 7-day periods.
Related Therapeutic Areas
Sponsors
Leads: KU Leuven
Collaborators: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov