Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
bowel e-diary
Diagnostic testThis bowel diary will be available on the smartphone in the form of an application.
Treatment groups
158 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Pre-Delphi patient focus groupNo intervention 0 interventions
Group B: Delphi surveyNo intervention 0 interventions
Group C: Post-Delphi patient focus groupNo intervention 0 interventions
Group D: Usability of e-diaryExperimental treatment 1 intervention
Group E: Psychometric properties of e-diaryExperimental treatment 1 intervention
Group F: Bowel symptoms in Watch and WaitExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
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.
Time frame
12 months3
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.
Time frame
12 months4
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.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
KU Leuven
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
Source ClinicalTrials.gov