UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063524 |
|---|---|
| Receipt number | R000072703 |
| Scientific Title | A multicenter study of a smartphone-based web questionnaire for monitoring health status after radiotherapy |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/05 13:41:48 |
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Basic information
Public title
A multicenter study of a smartphone-based web questionnaire for monitoring health status after radiotherapy
Acronym
A multicenter study of a smartphone-based web questionnaire for monitoring health status after radiotherapy
Scientific Title
A multicenter study of a smartphone-based web questionnaire for monitoring health status after radiotherapy
Scientific Title:Acronym
A multicenter study of a smartphone-based web questionnaire for monitoring health status after radiotherapy
Region
| Japan |
Condition
Condition
Breast cancer and prostate cancer
Classification by specialty
| Breast surgery | Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of a smartphone-based web questionnaire for monitoring health status during and after radiotherapy, added to usual care with clinician review of responses, using the questionnaire completion rate as the primary outcome.
Basic objectives2
Others
Basic objectives -Others
Feasibility of remote health monitoring using a web questionnaire
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Questionnaire completion rate: the proportion of participants who provide valid responses to at least 60% of questionnaires distributed through 90 days after completion of radiotherapy.
Key secondary outcomes
Usability questionnaire responses, longitudinal changes in symptom severity and health status visual analogue scale, withdrawal, and operational problems including delivery failures, assessed through 90 days after radiotherapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In addition to usual care, participants complete a smartphone-based web questionnaire and clinicians review responses within two working days. Questionnaires are distributed every 7 days during radiotherapy, at completion, and 7, 14, 21, 28, 42, 56 and 90 days after completion.
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
Patients aged 18 years or older receiving postoperative radiotherapy for breast cancer or definitive radiotherapy for prostate cancer. The patient or family member can receive email and complete the web questionnaire; an email address accessible to the patient is required, and a family member using their address must attend the clinic. The patient provides electronic informed consent and the treating clinician completes enrollment.
Key exclusion criteria
Patients judged unable to provide informed decisions because of cognitive impairment, unable to continue responding because of poor general condition, or otherwise unsuitable as judged by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7312
keiichi.jingu.e8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Takeda |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7312
Homepage URL
kazuya.takeda.a8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Radiation Oncology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
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
東北大学病院（宮城県）、東北医科薬科大学病院（宮城県）、みやぎ県南中核病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2026 | 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
Undecided. Any future use or sharing for research will require ethics review and appropriate consent or notification and an opportunity to opt out.
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 09 | 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 | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072703
