UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056331 |
|---|---|
| Receipt number | R000064360 |
| Scientific Title | Development of a collaborative monitoring system between a hospital and community pharmacy using a cancer patient support app for breast cancer outpatients treated with abemaciclib |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2024/12/02 14:58:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a collaborative monitoring system between a hospital and community pharmacy using an app for breast cancer outpatients treated with abemaciclib
Acronym
Development of a monitoring system using an app
Scientific Title
Development of a collaborative monitoring system between a hospital and community pharmacy using a cancer patient support app for breast cancer outpatients treated with abemaciclib
Scientific Title:Acronym
Development of a collaborative monitoring system between a hospital and community pharmacy using an app
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness among patients, pharmacists, and physicians after establishing a collaborative hospital-pharmacy monitoring system using an app in abemaciclib treatment of breast cancer in outpatient setting
Basic objectives2
Others
Basic objectives -Others
burden, anxiety, and satisfaction of patients, physicians, and community pharmacy pharmacists
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
burden, satisfaction, and anxiety associated with app use by patients, pharmacy pharmacists, and physicians(The survey was conducted at two time points: before implementation and in the 6th month after implementation.)
Key secondary outcomes
adverse events, adherence, relative dose intensity (RDI),app input implementation rate, duration of treatment (days) and time to treatment failure (TTF), number of emergency consultations/admissions (times) associated with AEs, interview times at the outpatient pharmacist office (time to check the medication status and symptoms), number of times the pharmacist confirmed the patient's input (the number of times an alert message was confirmed), number of times free messages were added to the diary in the app (from patients to pharmacists and from pharmacists to patients), number of direct calls to the outpatient pharmacist office and the time (minutes) spent on that call.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient is 20 years of age or older at the time consent is obtained
Patients with access to a smartphone
Patients who have given written consent to the study
Key exclusion criteria
Patients who are unable to use smartphones
Patients with brain metastases and associated cognitive dysfunction
Patients participating in another clinical study within 28 days prior to enrollment
Patients with a performance status of 3 or higher
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Maki |
| Middle name | |
| Last name | Todo |
Organization
Saitama Medical University Saitama International Medical Center
Division name
pharmacy
Zip code
3501298
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
0429844111
maki.todo0628@gmail.com
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Todo |
Organization
Saitama Medical University Saitama International Medical Center
Division name
pharmacy
Zip code
3501298
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
0429844646
Homepage URL
m_todo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Saitama International Medical Center
Institute
Department
Personal name
Maki Todo
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Saitama International Medical Center Clinical Research Appropriateness Promotion Center
Address
1397-1 Yamane, Hidaka, Saitama, Japan
Tel
0429844523
chikens@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
Results
This system reduced the burden and anxiety of both those communicating and those checking symptoms, and increased the satisfaction of patients, physicians, and community pharmacy pharmacists. The median medication adherence rate based on pill counts and the median medication possession ratio were 94.7% and 0.97, respectively.Except for five postoperative patients who discontinued treatment for unavoidable reasons, all patients continued treatment. There was no hospitalization due to adverse events.
Results date posted
| 2024 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gender: 21 female, median age (range): 55.0 (42-76), performance status: 0 in 19 patients, 1 in 2 patients, abemaciclib was administered to 6 patients for progressive recurrence and after surgery in 15 patients.
Participant flow
Adverse events
The all-grade symptoms were diarrhea in 100%, abdominal pain in 85.7%, fatigue in 66.7%, skin rash in 61.9%, and stomatitis in 57.1%. Grade 3 non-hematologic toxicity was diarrhea in only 2 of 21 patients.
Outcome measures
burden, satisfaction, and anxiety associated with app use by patients, pharmacy pharmacists, and physicians
Adverse events, Adherence,Relative dose intensity (RDI),App input implementation rate (%), Duration of treatment (days) and time to treatment failure (TTF), Number of emergency consultations/admissions (times) associated with AEs, Interview times at the outpatient pharmacist office (time to check the medication status and symptoms), Number of times the pharmacist confirmed the patient's input (the number of times an alert message was confirmed), Number of times free messages were added to the diary in the app (from patients to pharmacists and from pharmacists to patients), Number of direct calls to the outpatient pharmacist office and the time (minutes) spent on that call.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
A prospective observational study was conducted to evaluate the outcome measures.
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064360
