UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056035 |
|---|---|
| Receipt number | R000064013 |
| Scientific Title | Study of the benefits of collaboration between community and hospital pharmacists using electronic patient-reported outcomes (ePRO) |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2026/02/01 18:07:28 |
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Basic information
Public title
Study of the benefits of collaboration between community and hospital pharmacists using electronic patient-reported outcomes (ePRO)
Acronym
PHARE-ONC 02 RT (Pharmacy and Hospital Alliance on Remote Engagement in Oncology 02 Rice Triangle Model) Study
Scientific Title
Study of the benefits of collaboration between community and hospital pharmacists using electronic patient-reported outcomes (ePRO)
Scientific Title:Acronym
PHARE-ONC 02 RT (Pharmacy and Hospital Alliance on Remote Engagement in Oncology 02 Rice Triangle Model) Study
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In recent years, electronic patient-reported outcomes (ePRO) have been used to screen and monitor adverse events. Patient PRO-CTCAE adverse event ratings are communicated by community pharmacists to hospital pharmacists via tracing reports. Yaku Yaku Renkei (collaboration between community pharmacist and hospital pharmacist) using this ePRO is expected to prevent adverse events and reduced QOL without burdening hospital operations and lead to patient satisfaction with treatment. It is expected to lead to patient satisfaction with treatment. This study aims to evaluate the usefulness of Yaku Yaku Renkei through ePRO.
Basic objectives2
Others
Basic objectives -Others
HRQoL and Satisfaction of patients with this program
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EuroQol 5 dimensions 5-level(EQ-5D-5L)
Key secondary outcomes
Person-centred primary care measure (PCM) at the end of the study
Number of patients followed up
Number of tracing reports
Number of Gan Yakubutsu Ryoho Taisei Jujitsu Kasan (Cancer chemotherapy system enhancement surcharge)
Number of Renkei Jujitsu Kasan (coordination system enhancement surcharge)
Consultation and Relational Empathy (CARE) measure at end of study
Pharmacist's prescription suggestion
Proportion of prescription suggestions made by pharmacists that were accepted by physicians
Proportion of ePRO responses and alerts
Number of Tokutei Yakuzai Kanri Shido Kasan 2 (specific medication management and consultation surcharge)
Number of telephone follow-ups
End of study questionnaire for healthcare professionals and patients
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients receiving pharmacotherapy for cancer
Patients with a diagnosis of malignancy
ECOG performance status 0-2
Age >=20 years at time of consent
Prognosis expected to be at least 6 months as determined by physician
Written informed consent
Smartphone-enabled patients (or caregiver accessible)
Key exclusion criteria
Patients with obvious self-report difficulties due to their mental illness or cognitive impairment
Concurrent participation in other PRO studies
Patients with difficulty using a smartphone due to illness, adverse events, etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kohyama |
Organization
Saitama Medical University International Medical Center
Division name
Department of Pharmacy
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4190
kohyama@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kohyama |
Organization
Saitama Medical University International Medical Center
Division name
Department of Pharmacy
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4190
Homepage URL
kohyama@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
KAKEHASHI Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center, CCRI
Address
1397-1 Yamane, Hidaka, Saitama, Japan
Tel
042-984-4523
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
埼玉医科大学国際医療センター（埼玉県）、アポック日高センター前薬局 1 号店（埼玉県）、アポック日高センター前薬局 2 号店（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 05 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Interim analyses data have been reported
Final analyses will be reported soon
Management information
Registered date
| 2024 | Year | 11 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064013
