Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

Rectal Cancer Clinical Trial

— Treatable  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06274190
• Other study ID #: S68746
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: KU Leuven
• Contact: Inge Geraerts, PhD
• Phone: +3216329120
• Email: inge.geraerts[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Colorectal cancer is the 2nd and 3rd most common cancer in women and men, respectively and represents approximately 13% of all new cancer diagnoses, with 40% of cases specifically situated in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, given the improved oncological results, functional outcomes, such as bowel symptoms, become more and more important. Approximately 60-90% of RC patients are affected with a wide range of new onset bowel symptoms (incontinence for flatus or feces (solid, liquid), frequent bowel movements, urgency, clustering of defecation and evacuation problems) immediately after rectal treatment. The combination of these specific bowel symptoms and their impact on quality of life (QoL) has been summarized in an international consensus definition and is referred to as the Low Anterior Resection Syndrome (LARS).

Major LARS has an important impact on QoL and has major health economic consequences. This is attributable to its high prevalence after RC treatment, the chronic nature of symptoms and the limited evidence of available therapeutic options. This context leads to repetitive medical consultations, additional technical examinations which are often not very useful and need for prolonged medical treatment (multiple drug regimens), with often limited therapeutic gain. Furthermore, there is a lack of a comprehensive scoring system to identify the different aspects of LARS, leading to inadequate diagnostics and follow-up of symptoms. Based on these considerations, there is a clear need for a comprehensive scoring system for identification of the different aspects of LARS and monitoring of therapeutic treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: March 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 diagnosed with a rectal tumour based on a pathology report.

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 surgery, previous pelvic radiation or rectal surgery for non-cancer reasons.

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Rectal Cancer
• Rectal Neoplasms

Intervention

Diagnostic Test:
• bowel e-diary
This bowel diary will be available on the smartphone in the form of an application.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Selection of items for the newly developed bowel diary	The selection of items for a comprehensive bowel diary in patients with rectal cancer is based on a literature review, a patient focus group and an international Delphi survey. The patient focus group is recorded using an audio and video recording. This recording is transcribed verbatim by the researcher into a Word document. The transcription will be analyzed using NVIVO 9 software. In this Delphi survey, a multidisciplinary group of experts 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.	12 months
Primary	Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants	Content validation of the newly developed bowel diary will be tested during interview in the post-Delphi patient focus group. This focus group is recorded using an audio and video recording. This recording are transcribed verbatim by the researcher into a Word document. The transcription will be analyzed using NVIVO 9 software.	12 months
Primary	The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer	The participants will be asked to use a newly developed electronic bowel diary for 7 consecutive days. This bowel diary will be available on the smartphone in the form of an application. After 7 days, the usability of this e-diary will be assessed with the System Usability Scale (SUS). The SUS is a questionnaire consisting of 10 items, utilizing a 5-point Likert scale to measure users' perceived satisfaction with the system. It includes two subscales focusing on usability and learnability. Scores on the SUS range from 0 to 100, with no direct correlation to percentiles (i.e., a score of 60 does not signify a usability level of 60%). Instead, a score of 70 points or higher is commonly employed as an initial threshold indicating acceptable usability. This benchmark is derived from the overall mean of more than 200 studies covering various systems and products.	12 months
Primary	The usability of the newly developed e-diary will be evaluated through conversations with patients who have undergone rectal surgery for rectal cancer, after these patients have used the e-diary for seven consecutive days	Participants will be instructed to use a newly developed electronic bowel diary via a smartphone app for seven consecutive days. The research will then conduct conversations with the participants covering aspects such as complexity, the need for additional support, application coherence, user-friendliness, pre-existing knowledge requirements, and suggestions for improvement. Audio and video recordings of these conversations will be transferred to the researcher's computer and subsequently transcribed into a Word document. The transcriptions will be analyzed using NVIVO 9 software.	12 months
Primary	Construct validity of the newly developed bowel e-diary	For the determination of the construct validity, published literature will be used to generate hypotheses regarding bowel symptoms after RC treatment. The responses recorded in the e-diaries by participants, who diligently maintained entries for a continuous period of 7 days, will be systematically analyzed and compared against the formulated hypotheses.	12 months
Primary	Criterion validity of the newly developed bowel e-diary	Criterion validity will be measured in patients, comparing the relationship between the newly developed e-diary and an accepted current measure (e.g. LARS score). The participants will be asked to use the newly developed electronic bowel diary for 7 consecutive days.	12 months
Primary	Test-retest reliability of the newly developed bowel e-diary	To investigate the test-retest reliability of the newly developed bowel e-diary, patients will have to fill out the bowel diary application twice, each time for a continuous period of 7 days, during a period when the disorder and treatment do not change (i.e., after the end of adjuvant treatment and/or after closure of an eventual temporary postoperative ileostomy).	12 months
Primary	Responsiveness of the newly developed bowel e-diary in patients after rectal surgery for rectal cancer. The newly validated e-diary is the primary outcome.	To evaluate the responsiveness of the new bowel e-diary, which measures its ability to detect actual changes over an anticipated time frame (before and after treatment), patients scheduled for specific treatments (sacral nerve stimulation/ondansetron) will be asked to use the e-diary twice. This involves recording entries before and two weeks after the treatment, each for a continuous period of 7 days.	12 months