UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061901 |
|---|---|
| Receipt number | R000070828 |
| Scientific Title | Beyond Adherence: Safety Culture, Collective Awareness, and Psychological Harm in Oral Anticancer Therapy: An integrative review |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/14 17:44:34 |
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Basic information
Public title
Beyond Adherence: Safety Culture, Collective Awareness, and Psychological Harm in Oral Anticancer Therapy: An integrative review
Acronym
Beyond Adherence: Safety Culture, Collective Awareness, and Psychological Harm in Oral Anticancer Therapy: An integrative review
Scientific Title
Beyond Adherence: Safety Culture, Collective Awareness, and Psychological Harm in Oral Anticancer Therapy: An integrative review
Scientific Title:Acronym
Beyond Adherence: Safety Culture, Collective Awareness, and Psychological Harm in Oral Anticancer Therapy: An integrative review
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To synthesize evidence on team-based oral anticancer treatment approaches based on a safety culture to clarify mechanisms affecting the quality of broad treatment implementation, including psychological distress, adherence rates, safety, and quality of life in organizational structures and team processes
Basic objectives2
Others
Basic objectives -Others
To synthesize evidence on a team-based oral anticancer treatment approach based on a safety culture and consider the role of nurses in organizational structure and team processes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological harm during team-based oral anticancer treatment approaches based on safety culture
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Studies involved adult patients receiving oral chemotherapy either on an outpatient or home basis.
2) Research related to team-based care models and organizational or interdisciplinary interventions that consider safety and culture in the provision of oral therapy .
3) Research based on one of the above methods: quantitative, qualitative, mixed methods, implementation research, or quality improvement design.
4) Targeting at peer-reviewed papers or authoritative reports that provide sufficient methodological detail for evaluation and extraction.
Key exclusion criteria
1) Studies are excluded if they did not involve an oral anticancer therapy context, including infusion-only regimens without an oral component.
2) Studies are excluded if they focusing exclusively on pharmacologic efficacy without consideration of care processes, team functioning, or system-level factors.
3) Reports unrelated to safety culture or team-based care, and that do not address implementation outcomes related to psychological or compliance, are excluded
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Komatsu |
Organization
Kindai University
Division name
Faculty of Nursing
Zip code
590-0197
Address
1-14-1 Mihara-dai, Minami-ku, Sakai, Osaka
TEL
+81-72-288-7222
hiroko.koma@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Komatsu |
Organization
Kindai University
Division name
Faculty of Nursing
Zip code
590-0197
Address
1-14-1 Mihara-dai, Minami-ku, Sakai, Osaka
TEL
+81-72-288-7222
Homepage URL
hiroko.koma@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Self-financing
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
Not applicable
Address
Not applicable
Tel
+81-72-288-7222
hiroko.koma@med kindai.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 | 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
| 2025 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Electronic searches will be conducted on PubMed and CINAHL, supplementing the Cochrane Library (CENTRAL) search for literature related to oral anticancer therapy (OAT) and adherence rates.
The title and abstracts of retrieved articles in the peer-reviewed scientific literature will be two researchers will be screened by two researchers, with criteria based on the title and abstract listing. Literature that meets the criteria is obtained, read independently by two researchers, and inclusion and exclusion criteria are applied. Differences of opinion are resolved through discussion and consensus is reached.
As this study is an integrated review, approval from an ethics committee was not obtained.
Management information
Registered date
| 2026 | Year | 06 | Month | 14 | Day |
Last modified on
| 2026 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070828
