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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer; LARS - Low Anterior Resection Syndrome
• Intervention / Treatment: Diagnostic test: bowel e-diary

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inge Geraerts, PhD; Phone Number: +3216329120; Email: inge.geraerts@kuleuven.be
• Study Contact Backup: Name: Liesbet Lauwereins, MSc.; Phone Number: +3216379147; Email: liesbet.lauwereins@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Patients diagnosed with a rectal tumour based on a pathology report

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: bowel e-diary; This bowel diary will be available on the smartphone in the form of an application.
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.	Diagnostic test: bowel e-diary; This bowel diary will be available on the smartphone in the form of an application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Inge Geraerts, PhD, KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): April 29, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Care pathway; Quality of Life (QoL); Bowel diary
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Low Anterior Resection Syndrome
• Other Study ID Numbers: S68746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No