UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061852 |
|---|---|
| Receipt number | R000070758 |
| Scientific Title | Adherence to Safe Handling Practices at Home After Video-Based Education for Oral Anticancer Agents: A Single-Arm Intervention Study |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/09 22:30:57 |
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Basic information
Public title
A Study of Video-Based Education for Safe Handling of Oral Anticancer Drugs at Home
Acronym
OAA-Safe Home Video Study
Scientific Title
Adherence to Safe Handling Practices at Home After Video-Based Education for Oral Anticancer Agents: A Single-Arm Intervention Study
Scientific Title:Acronym
OAA-SafeHome Video Study
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the usefulness of video-based patient education on safe handling of oral anticancer agents at home by assessing adherence to safe handling practices after the intervention and changes in knowledge and self-efficacy before and after video-based education.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Core adherence rate to safe handling practices for oral anticancer agents at home at T1, defined as the second treatment cycle after discharge in the outpatient or inpatient setting. The rate will be assessed using five core behavior items (G1, G2, G3, G9, and G10). Each "yes" response will be scored as 1 and each "no" response as 0 to calculate a core adherence score (0-5), which will be converted to a percentage (0-100%). The mean and 95% confidence interval will be calculated.
Key secondary outcomes
1. Change in knowledge score before and after video-based education (T1-T0). 2. Change in self-efficacy score before and after video-based education (T1-T0). 3. Satisfaction, acceptability, and perceived usefulness of video-based education. 4. Proportion of patients with increased anxiety after video viewing. 5. Proportion of patients with decreased motivation for treatment after video viewing. 6. Associations between adherence rate and knowledge score, self-efficacy score, and patient characteristics. 7. Item-level applicability and adherence rates among applicable participants. 8. Estimated reduction in pharmacist counseling time and personnel costs
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will view a standardized educational video on safe handling of oral anticancer agents at home, followed by pharmacist-led question-and-answer counseling and teach-back. Knowledge and self-efficacy will be assessed before the intervention, and video evaluation and psychological impact will be assessed after viewing. At the second treatment cycle after discharge, safe handling practices at home, knowledge, and self-efficacy will be reassessed.
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 with gastrointestinal cancer who are chemotherapy-naive and newly start a regimen including oral anticancer agents during hospitalization. 2. Patients who provide written informed consent to participate in the study. 3. Patients aged 18 years or older on the date of registration.
Key exclusion criteria
1. Patients who have previously received education on exposure prevention for anticancer agents. 2. Patients who have difficulty viewing the video because of visual impairment, hearing impairment, or other reasons. 3. Patients with cognitive impairment. 4. Patients who do not provide informed consent. 5. Patients judged to have difficulty participating in the study because of clinically significant psychiatric or neurological symptoms. 6. Patients judged by the physician to be unsuitable for enrollment.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Yamaguchi |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Pharmacy
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
03-3570-0215
masakazu.yamaguchi@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Tanigawa |
| Middle name | |
| Last name | Hiromu |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Pharmacy
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
03-3570-0215
Homepage URL
hiromu.tanigawa@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
Tel
03-3570-0215
med.shinsa@jfcr.or.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 | 06 | Month | 15 | 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 | 05 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a prospective, single-center, single-arm before-after interventional study evaluating video-based education for safe handling of oral anticancer agents at home.
From the date of research implementation permission to 2027/09/30, or until enrollment of 56 participants, whichever occurs first.
Each participant will be followed until approximately 1 month, within 2 weeks before or after registration, corresponding to the second treatment cycle.
Management information
Registered date
| 2026 | Year | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070758
