UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061721 |
|---|---|
| Receipt number | R000070638 |
| Scientific Title | Randomized controlled trial of electronic Patient-Reported Outcome Monitoring with Integrated hospital-community pharmaciSt Engagement for diverse outpatient anticancer chemotherapy |
| Date of disclosure of the study information | 2026/05/29 |
| Last modified on | 2026/05/28 17:18:57 |
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Basic information
Public title
Randomized controlled trial of electronic Patient-Reported Outcome Monitoring with Integrated hospital-community pharmaciSt Engagement for diverse outpatient anticancer chemotherapy
Acronym
PRO-MISE (Patient-Reported Outcome Monitoring Integrating PharmaciSt Engagement across Diverse Cancers) trial
Scientific Title
Randomized controlled trial of electronic Patient-Reported Outcome Monitoring with Integrated hospital-community pharmaciSt Engagement for diverse outpatient anticancer chemotherapy
Scientific Title:Acronym
PRO-MISE (Patient-Reported Outcome Monitoring Integrating PharmaciSt Engagement across Diverse Cancers) trial
Region
| Japan |
Condition
Condition
Adults with solid tumors or hematologic malignancies receiving or scheduled to receive outpatient systemic anticancer chemotherapy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether pharmacist collaboration through smartphone-based ePRO monitoring improves health-related quality of life (HRQoL), compared with usual care, among patients with diverse cancer types receiving outpatient systemic anticancer chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Three-category change in the EORTC QLQ-C30-derived Overall HRQoL score from baseline to Week 12 (3 months), defined as improved (change >= +5 points), worsened (change <= -5 points), or stable otherwise.
Key secondary outcomes
Secondary endpoints include three-category change in Overall HRQoL score from baseline to Week 24; absolute change in Overall HRQoL score from baseline to Weeks 12 and 24; changes in prespecified EORTC QLQ-C30-derived scores (physical function, symptom control, global health status, and financial difficulties) from baseline to Weeks 12 and 24; overall survival through Week 24; and unplanned chemotherapy discontinuation, hospitalization, or emergency department visits. Pharmacist process metrics include institution and community pharmacist follow-up contacts, tracing reports, pre-consultation interviews, pharmaceutical recommendations to treating physicians, and physician acceptance. Exploratory endpoints include claims activity, health-economic analyses, user-experience surveys, and additional patient-reported metrics such as EQ-5D-5L.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Other |
Interventions/Control_1
ePRO monitoring group: Patients complete weekly PRO-CTCAE assessments via smartphone for 24 weeks. For each patient, 16 symptom items, comprising 30 attribute-level questions, are selected from the validated Japanese PRO-CTCAE item library. All responses are transmitted to the designated community pharmacy, and Grade 3 or higher responses are highlighted. The pharmacist reviews the responses and, as needed, contacts, follows up with, and counsels the patient. If a disease- or treatment-related issue is identified, the pharmacist submits a structured tracing report to the treating institution as needed. All actions and physician acceptance status are recorded in the EDC system.
Interventions/Control_2
Usual care group: Patients receive standard outpatient cancer care for 24 weeks without pharmacist-linked smartphone-based ePRO monitoring. Routine pharmacist services continue without restriction in both groups, and both groups receive standardized baseline education on self-management of common disease- and treatment-related symptoms.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Aged >= 20 and < 90 years at informed consent.
2) Diagnosed with a solid tumor or hematologic malignancy.
3) Receiving or scheduled within 1 month to receive outpatient systemic anticancer chemotherapy, including cytotoxic chemotherapy, molecularly targeted therapy, or immune checkpoint inhibitors.
4) Expected to continue treatment and follow-up at the same institution and community pharmacy for >= 12 weeks (>= 3 months).
5) Able to use a smartphone in Japanese, with assistance if needed.
6) ECOG performance status 0-2.
7) Providing written or electronic informed consent.
Key exclusion criteria
1) Receiving hormone therapy alone as outpatient systemic anticancer chemotherapy.
2) Diagnosed with acute leukemia.
3) Planned cancer-directed surgery or stem cell transplantation within 12 weeks of enrollment.
4) Cognitive impairment precluding weekly PRO-CTCAE self-completion, per recruiting pharmacist.
5) Concurrent enrollment in another study collecting PROs returned to healthcare providers.
Target sample size
880
Research contact person
Name of lead principal investigator
| 1st name | Shunya |
| Middle name | |
| Last name | Ikeda |
Organization
International University of Health and Welfare
Division name
Graduate School of Medicine, Department of Social Medical Sciences
Zip code
107-8402
Address
Akasaka, Minato-ku, Tokyo 107-8402, Japan
TEL
03-5574-3900
shunya@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tohru |
| Middle name | |
| Last name | Takebe |
Organization
KAKEHASHI Inc.
Division name
Patient Engagement
Zip code
105-0003
Address
Sumitomo Fudosan Hibiya Bldg., 5th Floor 2-8-6, Nishishinbashi, Minato-ku, Tokyo 105-0003, Japan
TEL
03-6825-2058
Homepage URL
t.takebe@kakehashi.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
KAKEHASHI Inc.
Name of secondary funder(s)
Not applicable
IRB Contact (For public release)
Organization
Ethical Committee of International University of Health and Welfare
Address
852 Hatakeda, Narita City, Chiba 286-8520
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070638
