- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446051
Development and Testing of a TTDSS for Cancer Patients (TTDSS)
Development and Testing of a Telephone Triage Decision Support System (TTDSS) for Cancer Patients
Study Overview
Status
Conditions
Detailed Description
This study aimed to understand the use of different educational models (eRAPID-MV) and self-management behaviors of cancer patients in managing treatment-induced side effects at home. To this end, interventions were provided through a decision support system involving telephone triage. Finally, the study explored the effectiveness of the intervention method (eRAPID-MV & TTDSS) on patient care outcomes and telephone triage service outcomes.
Study design/setting This was a prospective, nonrandomized clinical study.Study procedures and data collection were carried out at the outpatient department of St. Martin De Porres Hospital, Taiwan. The trial followed the Declaration of Helsinki and Good Clinical Practice guidelines for trial conduct. Participants a breast surgeon or colorectal surgeon or hematologist oncologist were invited or referred to participate in the research project. Participants provided their written informed consent prior to taking part in this 24-week program. Participants has received a weekly reminder from the APP or emails to complete an online TRAEs (eRAPID-MV) assessment at home. Participants used an electronic device (e.g., smart phone, tablet, computer) with real-time electronic data transfer to the Health Care Information System (HIS). During the study period, participants were compared to a usual care control group on patient care outcomes and telephone screening service outcomes.
Interventions Two key intervention components were standardized across participating hospitals: Phase I Interventions: eRAPID-MV system-a) TRAEs surveys, b) survey feedback reports, and c) patient self-management and clinical alerts; Phase II Interventions: TTDSS.
The Phase I intervention details are as follows: (1) The patients completed the TRAEs survey-18 items. Based on the survey results, the eRAPID-MV system provided a summary report of the traffic signal and recommendations to the patient for seeking medical advice (red or yellow light), and a link to the TRAEs websites for self-management (green light). The TRAEs websites on health education summarized available information from symptom management guidelines, telephone triage protocols for nurses, and published articles. (2) The survey results were also integrated into the hospital information system (HIS) and case management system (Cancer Patient Registry) to enable the clinician and case managers to access report summaries and review patient-reported outcomes for severe TRAEs. (3) All the patients (experimental group) completed the TRAEs survey every week during their active treatment period, and the eRAPID-MV system's automatic schedule was sent to them. (4) The intervention duration was 24 weeks. (5) Participants were asked to fill out a satisfaction survey on weeks 2, 12, and 24. The system usability scale (SUS) was also used on the day of the final survey. Finally, patients were recruited to attend a single interview that assessed their views on the eRAPID-MV system. Participation was voluntary, and the interview lasted approximately 20-30 minutes.
The Phase II intervention details are as follows: (1) a phone consultation with the oncology case manager was determined based on the patient's TRAEs (red or yellow light-experimental group or the need for a return visit). The oncology case manager referred to the last TRAEs data and inquired about the patient's present condition. Based on the information and the purpose of the patient's call, the oncology case manager evaluated the severity of TRAEs by referring to the guidelines for TTDSS. The patient received the best possible recommendation to help manage TRAEs based on a summary report of the traffic signal. When the light was red or yellow, the oncology case manager arranged for immediate outpatient or emergency medical treatment and assisted in hospitalization if necessary. (2) Following Phase II intervention (TTDSS) for 72 hours, the first post-test was performed to assess the immediate effects on the patient. (3) Long-term effects were also evaluated, including the effectiveness of patient care outcomes and telephone triage service outcomes on cancer patients after 24 weeks of intervention. (4) Finally, the oncology case manager asked to attend a single interview that assessed their views on the TTDSS. Participation was voluntary, and the interview lasted approximately 20-30 minutes.
Data collection and management For the 24-week study period, participants were evaluated at baseline, and every week (experimental group) or every 3 weeks (control group) by TRAEs assessment. Participants were asked to complete 3, brief, self-administered questionnaires: the treatment-induced adverse events (TRAEs) questionnaire, satisfaction questionnaire, system usability scale (SUS), and interview with patients (experimental group). All questionnaires and the consent form were translated into Chinese (Traditional) by a certified translator. The TRAEs data were fully integrated into HIS and the case management system (including the Cancer Patient Registry) of St Martin De Porres Hospital (id: STM-IRB-22B-001-2022-04). Data were processed anonymously; therefore, data for which participants' identities could be identified were omitted. Strict safety and confidentiality measures were established in the archives of clinical trial institutions. Every six months, the Institutional Review Board (IRB) will be responsible for checking the status of the study and the quality of the data collected.
Sample size calculation The multiple linear regression statistical method was followed to estimate the sample size of the cluster, and the number of patients required for the study was determined accordingly. The total sample size required for the computer software calculation was 114. Considering the attrition rate of approximately 20%, the estimated sample size for this study was at least 136, and the average sample size for each group was at least 68.
Statistical analysis Descriptive statistics, including means, standard deviations, frequencies, and percentages, and chi-square tests and independent t-tests, were used to test the homogeneity of context-level factors (e.g. demographic characteristics, disease status, and family caregiver support) between the two groups. Binary logistic regression and polynomial linear regression were used to analyze the factors influencing self-management behaviors. Inferential statistics, including paired sample t-test, 2-group sample t-test, Mc Nemar's test, and analysis of covariance (ANCOVA), were used. Following the eRAPID- MV and TTDSS intervention, analyses were performed to assess changes in patient care outcomes (TRAEs severity, disconnection rate, hospitalization rate, retention rate, and completion rate) and triage service outcomes (ease of use of the system).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Chiayi City, Taiwan, 60069
- Recruiting
- St. Martin De Porres Hospital
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Contact:
- Chen-Chen Kuo, master
- Phone Number: 2277 886-52756000
- Email: 1836stm@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
New patients and take the TRAEs Questionnaire on week.
|
Phase I Interventions:eRAPID-MV(TRAEs survey)
Phase I Interventions:TTDSS
|
No Intervention: Control group
Control Group:Old patients and usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TRAEs severity
Time Frame: 24 weeks
|
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
Time Frame: 24 weeks
|
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
Time Frame: 24 weeks
|
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
Time Frame: 24 weeks
|
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
Time Frame: 24 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compliance with care recommendations
Time Frame: 24 weeks
|
Operational definition: The compliance scale was measured by the researcher's self-developed the compliance with care recommendations based on the TTDSS with a dichotomous scale of compliance (1) and non-compliance (0), with a score range of 0-1, the higher scores representing higher compliance. |
24 weeks
|
patient satisfaction
Time Frame: 24 weeks
|
Operational definition: The satisfaction scales of eRAPID-MV and TTDSS were self-developed by the investigator with reference to relevant literature; one question each on this scale was measured on a five-point scale, "very dissatisfied" (1 point), "satisfied" (2 points), "fair" (3 points), "satisfied" (4 points), and "very satisfied" (5 points), with scores ranging from 1 to 5, with higher scores indicating higher levels of patient satisfaction. |
24 weeks
|
system usability
Time Frame: 24 weeks
|
Operational definition: Originally the System Usability Scale (SUS) created by John Brooke in 1986. SUS provides a quick and reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree (5 point) to Strongly disagree (1 point). The score range is 0-100, and the higher the score, the higher the usability of the system. In order to increase the reliability of the questionnaire, the odd numbered questions were used as positive questions and the even numbered questions were used as negative questions, and the survey was conducted in a positive and negative crossover manner. |
24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STM-IRB-22B-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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