UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058229 |
|---|---|
| Receipt number | R000066190 |
| Scientific Title | A randomized controlled trial of an educational intervention for community pharmacists to promote dialogue with cancer patients, focusing on practical communication support regarding dietary supplements and standard treatments |
| Date of disclosure of the study information | 2025/06/19 |
| Last modified on | 2025/06/19 23:47:18 |
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Basic information
Public title
A study to evaluate the effectiveness of an educational program that promotes dialogue between cancer patients and community pharmacists
Acronym
STEPS Study (Supplement and Treatment Education Program for Supportive Pharmacists)
Scientific Title
A randomized controlled trial of an educational intervention for community pharmacists to promote dialogue with cancer patients, focusing on practical communication support regarding dietary supplements and standard treatments
Scientific Title:Acronym
STEPS Study (Supplement and Treatment Education Program for Supportive Pharmacists)
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in knowledge, attitude, and confidence (KAC) among community pharmacists following an educational video-based intervention designed to promote dialogue with cancer patients regarding dietary supplements and standard treatments. The study also aims to assess the feasibility and usefulness of the intervention based on implementation rates and willingness to continue the support.
Basic objectives2
Others
Basic objectives -Others
education
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in pharmacists' knowledge, attitude, and confidence (KAC) scores before and after the educational intervention, as measured by a structured KAC questionnaire.
Key secondary outcomes
Implementation status of pharmacist-led support activities, including the rate of patient questioning and the number of leaflets distributed
Subjective evaluation of willingness to continue, integration into routine work, and perceived barriers after the intervention
Information collected by pharmacists from patients regarding their use of dietary supplements and complementary and alternative medicine (CAM), and whether they had received explanations about standard treatments
Patient-reported outcomes including perceived ease of consultation and understanding of standard treatments and dietary supplements
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pharmacists in the intervention group will view a 30-minute educational video on dietary supplements and standard cancer treatments, and for three months, they will conduct a practical intervention that includes asking cancer patients two questions (regarding experience of being recommended dietary supplements and receiving explanations about standard treatment), distributing informational leaflets, and recording patient responses.
Interventions/Control_2
Pharmacists in the control group will only view a 10-minute basic informational video on dietary supplements and standard treatments, without conducting any practical intervention such as patient questioning, leaflet distribution, or recording.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pharmacists working at community (insurance) pharmacies
Expected to remain in active pharmacy practice throughout the study period
Experience in providing services to cancer patients (receiving anticancer or supportive therapy) at least once a month
At least one year of pharmacy practice experience
Key exclusion criteria
Individuals who are expected to take a leave of absence or resign during the study period
Individuals who initially expressed willingness to participate but withdrew consent after explanation or during the intervention period
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okada |
Organization
School of Pharmaceutical Sciences, Wakayama Medical University
Division name
Department of Social and Community Pharmacy
Zip code
640-8156
Address
25-1 Shichibancho, Wakayama-shi, Wakayama 640-8156, Japan
TEL
073-488-3147
okada_h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yousuke |
| Middle name | |
| Last name | Nomura |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Wakayama Medical University
Division name
Department of Social and Community Pharmacy
Zip code
640-8156
Address
25-1 Shichibancho, Wakayama-shi, Wakayama 640-8156, Japan
TEL
073-488-3147
Homepage URL
m2499005@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB), Wakayama Medical University
Address
811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2025 | Year | 06 | Month | 19 | 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 | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066190
