UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061122 |
|---|---|
| Receipt number | R000069624 |
| Scientific Title | A before-and-after controlled trial evaluating the effectiveness of patient-reported outcomes in outpatient cancer chemotherapy |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/04/01 11:11:31 |
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Basic information
Public title
A before-and-after controlled trial evaluating the effectiveness of patient-reported outcomes in outpatient cancer chemotherapy
Acronym
A before-and-after controlled trial evaluating the effectiveness of patient-reported outcomes in outpatient cancer chemotherapy
Scientific Title
A before-and-after controlled trial evaluating the effectiveness of patient-reported outcomes in outpatient cancer chemotherapy
Scientific Title:Acronym
A before-and-after controlled trial evaluating the effectiveness of patient-reported outcomes in outpatient cancer chemotherapy
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
As a pilot study to evaluate the effectiveness of electronic patient-reported outcomes (PROs) for patients undergoing outpatient chemotherapy, we will evaluate the feasibility of PRO-CTCAE, patient-provider communication, and questionnaire responses to measure quality of life after cancer treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
PRO-CTCAE completion rate
Key secondary outcomes
Changes in EORTC-QLQ-C30 and FHUS before and after intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A system created by 3H MediSolutions, Inc. is downloaded onto the research participant's smartphone, and a membership number is registered without entering the research participant's name.
Pro-CTCAE is entered into the system once a week. If participants are unable to enter it themselves, a family member or medical professional will enter it.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with cancer, including solid tumors and hematologic cancers
(2) Cancer patients with recurrence or metastasis
(3) Patients starting a new cancer chemotherapy regimen (second-line or third-line treatment) in the outpatient chemotherapy room of the target facility
(4) Able to independently complete ePRO using a smartphone
Key exclusion criteria
(1) Those whose life expectancy is expected to be within three months
(2) Those deemed inappropriate by a doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mitsunori |
| Middle name | |
| Last name | Miyashita |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Nursing, Health Sciences
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7924
miya@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Nursing, Health Sciences
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7924
Homepage URL
satomi.kikuchi.q3@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069624
