Clinical trial · Interventional
Development and Testing of a TTDSS for Cancer Patients
Development and Testing of a Telephone Triage Decision Support System (TTDSS) for Cancer Patients
- 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)
This study aimed at testing the technical and clinical feasibility of the Mandarin Version of the electronic patient self-Reporting of Adverseev ents (eRAPID-MV) and the telephone triage decision support system (TTDSS) by testing them on patients with breast and colorectal cancer. The hypothesis of this study was the patients with breast and colorectal cancer who received eRAPID-MV and TTDSS were performing better on patient care outcomes and telephone screening service outcomes than patients who had not received eRAPID-MV and TTDSS. A non-randomized comparison trial was performed in St. Martin De Porres Hospital, Taiwan from July 2022 to April 2023. This study employed a quasi-experimental design to collect data from a treatment induced adverse events (TRAEs) questionnaire, a satisfaction questionnaire, and an interview with patients. It used the system usability scale (SUS) to assess data usability. 136 patients with breast cancer or colorectal cancer were unrolled and distributed in two groups. In Phase I, participants were selected based on convenience sampling and non-randomly assigned to an experimental group (N=68). They received chemotherapy and completed the eRAPID-MV measures-based TRAEs survey every week. The control group (N = 68) received usual care. The program duration was 24 weeks. At the end of the program, the researcher recruited participants from the experimental group based on voluntary recruitment for a single interview to assess their views on the eRAPID-MV system. The interview duration was approximately 20-30 minutes. Both groups completed the pre-test and post-test TRAEs questionnaire. In Phase II, when the TRAEs survey indicated a red light for experimental group, the eRAPID-MV system provided automatic recommendations to the patient to seek emergency medical services, or the patient contacted the case manager to deal with severe TRAEs. Simultaneously, the oncology case manager or oncologist received an alarm reminder immediately. Based on the TRAEs survey indication (red or yellow light) and consultation with the patient via a phone call, the oncology case manager reassessed the patient's TRAEs using TTDSS and scheduled their follow-up appointment accordingly. After 72 hours of intervention in Phase II (TTDSS), the first post-test was performed to assess the immediate effects. The long-term effects were evaluated at the end of the intervention, which lasted 180 days (6 months).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Treatment Side Effects | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the Mandarin Version of the electronic patient self-Reporting of Adverse-events (eRAPID-MV) | Device | — | UNRESOLVED |
| the telephone triage decision support system (TTDSS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- New patients and take the TRAEs Questionnaire on week.
- interventionNames
- Device: the Mandarin Version of the electronic patient self-Reporting of Adverse-events (eRAPID-MV)
- Device: the telephone triage decision support system (TTDSS)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Control Group:Old patients and usual care.
Primary outcomes (5)
- measure
- TRAEs severity
- timeFrame
- 24 weeks
- description
- Operational definitions: Calvett et al. (2021) and Richards et al. (2020) were used to develop the item assessment and severity grading of TRAEs based on the version 5.0 CTCAE scale (visualization of red, yellow, and green lights). Green events (CTCAE-1): mild AEs with self-management advice only; yellow events (CTCAE-2): moderate AEs with self-management advice, and recommend patient to a phone consultation with the oncology case manager; Red events (CTCAE-Grade 3 and 4): Severe AE recommend patients to be referred to a hospital as soon as possible within 24 hours. TRAEs severity was then graded on a scale of 1-4, with 4 being the most severed and 1 being not severed at all.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Are age 20 years or over * Aare eligible diagnosed with ICD-10 colorectal cancer (C18-C21) or breast cancer (C50), * Received chemotherapy for at least three months were Chinese literate. Exclusion Criteria: * Classification 0 (diagnosed in one hospital, treated in other hospitals) and category 3 (diagnosed in other hospitals, treated in other hospitals) cases of cancer * deceased patients * patients without a local telephone, mobile phone, or Internet access at home * illiterate patients or patients who cannot use mobile phones or the Internet.
References
Publications (0)
Data not yet available