UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056007 |
|---|---|
| Receipt number | R000063924 |
| Scientific Title | Electronic PRO-CTCAE for monitoring adverse events of cancer medication and collaboration between community and hospital pharmacists: a prospective observational study |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2026/02/01 18:06:29 |
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Basic information
Public title
Electronic PRO-CTCAE for monitoring adverse events of cancer medication and collaboration between community and hospital pharmacists: a prospective observational study
Acronym
PHARE-ONC 01 (Pharmacy and Hospital Alliance on Remote Engagement in Oncology 01) Study
Scientific Title
Electronic PRO-CTCAE for monitoring adverse events of cancer medication and collaboration between community and hospital pharmacists: a prospective observational study
Scientific Title:Acronym
PHARE-ONC 01 (Pharmacy and Hospital Alliance on Remote Engagement in Oncology 01) Study
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study objectives are to monitor adverse events of outpatient cancer pharmacotherapy by community pharmacists using ePRO to determine three things.
(i) Improved patient outcomes.
Community pharmacists and hospital pharmacists can share and use ePRO information to improve patient outcomes.
(ii) Assessment of operational feasibility
Reducing the workload of hospital staff and assessing the potential for task shifting from doctors and hospital pharmacists to community through monitoring by community pharmacists.
(iii) Identification of dissemination issues for ePRO monitoring and pharmacist follow-up by surveying patients and healthcare professionals to identify dissemination issues
Basic objectives2
Others
Basic objectives -Others
HRQoL, symptoms and physical function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Key secondary outcomes
Number of patients followed up
Proportion of informed consent
Proportion of PRO-CTCAE responses
Number of adverse events grade 3 or more
Number of tracing reports
Number of Tokutei Yakuzai Kanri Shido Kasan 2 (specific medication management and consultation surcharge) and Fukuyaku Joho Tou Teikyo-ryo (medication information provision surcharge)
Number of Renkei Jujitsu Kasan (coordination system enhancement surcharge)
Number of prescription suggestions and providing information made by pharmacists for physicians
Satisfaction (healthcare professionals and patients)
The Consultation and Relational Empathy (CARE) Measure
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
Patients receiving anticancer medications in participating hospitals and receiving medications from participating pharmacies with the following criteria
-A diagnosis of malignancy
-Outpatients receiving anticancer medications
-ECOG Performance Status of 0-2
->=20 to <100 years of age at the time of consent
-Written informed consent
-Patients with operable a smartphone or caregiver (etc.) accessible on behalf of the patients
Key exclusion criteria
Inappropriate patients with the following reasons as decided by health care professionals
-Patients with obvious difficulty using touch-screen electronic devices, or caregivers (etc.) with difficulty using the patient's electronic devices continuously and alternately
-Patients with obvious difficulties in assessing their own symptoms due to mental illness or cognitive impairment
-Concurrent participation in other PRO studies
-Other inappropriate patients as decided by health care professionals
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Imai |
Organization
Jichi Medical University / Jichi Medical University Hospital
Division name
Department of Pharmacology, Division of Clinical Pharmacology / Department of Pharmacy
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
TEL
0285-58-7388
imaiy@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Yamazaki |
Organization
International University of Health and Welfare Graduate School
Division name
Graduate School of Medicine
Zip code
107-0052
Address
4-1-26 Akasaka, Minato-ku, Tokyo, Japan
TEL
080-3019-7880
Homepage URL
s08-097my@nms.ac.jp
Sponsor or person
Institute
Jichi Medical University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee, International University of Health and Welfare
Address
852 Hatakeda, Narita City, Chiba 286-8520 Japan
Tel
0476-35-5600
rinri_md@iuhw.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
自治医科大学付附属属病院（栃木県）、聖隷浜松病院（静岡県）、浜松医療センター（静岡県）、アイン薬局 自治医大店（栃木県）、ココカラファイン薬局 自治医大前店（栃木県）、さくら薬局 自治医大前店（栃木県）、日本調剤 自治医大前薬局（栃木県）、杏林堂薬局 聖隷住吉病院前店（静岡県）、杏林堂薬局 新津店（静岡県）、杏林堂薬局 和合店（静岡県）、杏林堂薬局 高丘東店（静岡県）、杏林堂薬局 浜松医療センター前店（静岡県）、杏林堂薬局 志都呂店（静岡県）、杏林堂薬局 西伊場店（静岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | 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 | 10 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 01 | 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 | 10 | Month | 31 | 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=R000063924
