NCT05446051: TTDSS

Development and Testing of a TTDSS for Cancer Patients

Status unknown NA Last updated 17 March 2023

What this trial tests

NA trial testing the Mandarin Version of the electronic patient self-Reporting of Adverse-events (eRAPID-MV) in Treatment Side Effects in 136 participants. Status unknown.

Timeline

25 July 2022

Primary endpoint
6 November 2023

6 April 2024

Quick facts

Lead sponsor	St. Martin De Porress Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	136
Start date	25 July 2022
Primary completion	6 November 2023
Estimated completion	6 April 2024
Sites	1 location across Taiwan

Drugs / interventions tested

• the Mandarin Version of the electronic patient self-Reporting of Adverse-events (eRAPID-MV)
• the telephone triage decision support system (TTDSS)

Conditions studied

• Treatment Side Effects — all drugs for Treatment Side Effects →

Sponsor

St. Martin De Porress Hospital

Who can join

20 and older, any sex, with Treatment Side Effects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.