Development and Testing of a TTDSS for Cancer Patients

NCT05446051 | Unknown DMC

• 1 other identifier: STM-IRB-22B-001
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Treatment Side Effects

Keywords

Telephone Triage Decision Support System; Treatment Induced Adverse Events

Outcome Measures

Primary Outcomes (5)

• TRAEs severity

  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.

  24 weeks

• loss to follow-up rate

  Operational definition: The loss to follow-up rate is defined according to accreditation of Cancer Care Program by the Taiwan Cooperative Oncology Group. The numerator is the number of missing cases for breast and colorectal cancers for 3 months; the denominator is the number of missing cases for breast and colorectal cancers (total number of cases - number of deaths).

  24 weeks

• hospitalization rates

  Operational definition: TRAEs with a severity rating of yellow events and red events that require further hospitalization after assessment by an outpatient or emergency clinician. The numerator is the actual number of hospitalizations in the denominator; the denominator is the total number of severe yellow events and red events of TRAEs (excluding the number of deaths).

  24 weeks

• Retention rate

  Operational definition: The retention rate is defined according to accreditation of Cancer Care Program by the Taiwan Cooperative Oncology Group. The numerator is the number of missing cases for breast and colorectal cancers for 6 months; The denominator is the number of new cases of breast cancer and colorectal cancer (Class 1\~2) diagnosed in the hospital during the year.

  24 weeks

• treatment completion rates

  Operational definition: The treatment completion rate is defined according to accreditation of Cancer Care Program by the Taiwan Cooperative Oncology Group. The numerator is the number of cases in the denominator in which a single type of treatment (e.g. chemotherapy, radiation therapy) was completed within 6 months of the first treatment.; The denominator is the number of cases of breast cancer and colorectal cancer newly diagnosed (Class 1\~2) and treated (surgery, chemotherapy, radiotherapy) in our hospital in the current year.

  24 weeks

Secondary Outcomes (3)

• compliance with care recommendations

  24 weeks

• patient satisfaction

  24 weeks

• system usability

  24 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

New patients and take the TRAEs Questionnaire on week.

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

Control group

NO INTERVENTION

Control Group：Old patients and usual care.

Interventions

the Mandarin Version of the electronic patient self-Reporting of Adverse-events (eRAPID-MV) DEVICE

Phase I Interventions：eRAPID-MV(TRAEs survey)

Experimental Group

the telephone triage decision support system (TTDSS) DEVICE

Phase I Interventions：TTDSS

Experimental Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Martin De Porress Hospital: lead

Study Sites (1)

St. Martin De Porres Hospital

Chiayi City, 60069, Taiwan

RECRUITING

Study Officials

• Yueh-Ping Liu, Director

  Ministry of Health and Welfare

  STUDY CHAIR

Central Study Contacts

Chen-Chen Kuo, Chief

CONTACT

+886-5-275600; 1836stm@gmail.com

Chia-ti Huang, Chief

CONTACT

+886-5-275600; h00c@stm.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind(Participant)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental Group：New patients and take the TRAEs Questionnaire on week. Control Group：Old patients and usual care.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 6, 2022
• Study Start: July 25, 2022
• Primary Completion: November 6, 2023
• Study Completion: April 6, 2024
• Last Updated: March 17, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)