UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058508 |
|---|---|
| Receipt number | R000066895 |
| Scientific Title | Quantitative Validation of Questionnaires on Use of Tobacco and Nicotine Containing Products from the Perspectives of Adult Users and Their Adult Relatives in Japan |
| Date of disclosure of the study information | 2025/07/21 |
| Last modified on | 2025/07/17 23:53:13 |
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Basic information
Public title
Quantitative Validation of Questionnaires on Use of Tobacco and Nicotine Containing Products from the Perspectives of Adult Users and Their Adult Relatives in Japan
Acronym
Quantitative Validation of Questionnaires on Use of Tobacco and Nicotine Containing Products from the Perspectives of Adult Users and Their Adult Relatives in Japan
Scientific Title
Quantitative Validation of Questionnaires on Use of Tobacco and Nicotine Containing Products from the Perspectives of Adult Users and Their Adult Relatives in Japan
Scientific Title:Acronym
Quantitative Validation of Questionnaires on Use of Tobacco and Nicotine Containing Products from the Perspectives of Adult Users and Their Adult Relatives in Japan
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is not a clinical trial or a research activity; it is a testing activity with the purpose of evaluating and validating two questionnaires, which aim to assess exposure to tobacco and nicotine products (TNP). The questionnaires are (1) the Tobacco Exposure Questionnaire (TEQ) which will be completed by adult TNP users and (2) the Relatives' Questionnaire (RQ) which will be completed by adult relatives of adult TNP users living in the same household.
Basic objectives2
Others
Basic objectives -Others
Questionnaire validation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative evaluations will be performed to assess measurement properties of the questionnaires, including reliability and validity. For reliability, we will assess test-retest reliability to evaluate the consistency of responses to the same questions from the same set of adult participants within a short interval. For convergent validity (concordance), responses from adult relatives of adult TNP users will be compared to those from the adult TNP users themselves, evaluating the agreement between responses to questions that ask for the same information.
Key secondary outcomes
Base
Study type
Observational
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
Inclusion Criteria for TNP Users:
-Residing in Japan and able to speak/read Japanese language for the survey
-Age >=30 years at the time of consent
-Current/former cigarette (CIG) smoker and/or heated tobacco product (HTP) user (i.e., IQOS, Glo, Ploom)
-Capable of submitting an electronic informed consent to participate in the study
Inclusion Criteria for Relatives of TNP Users:
-Residing in Japan and able to speak/read Japanese language for the survey
-Age >=18 years at the time of consent
-Relatives of TNP users and living in the same house with TNP users
-Capable of submitting an electronic informed consent online to participate in the study
Key exclusion criteria
Exclusion Criteria for TNP Users and Relatives:
-Those who participated in the qualitative validation (an interview conducted prior to this survey) as a content validation for TEQ and RQ.
-Having more than one pair of TNP user and his/her relative living in the same household.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Russell |
| Middle name | |
| Last name | Miller |
Organization
Syneos Health Japan K.K.
Division name
Real World Research
Zip code
100-7012
Address
JP Tower 12F, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-6733-9690
russell.miller@syneoshealth.com
Public contact
Name of contact person
| 1st name | Xiaohe |
| Middle name | |
| Last name | Tang |
Organization
Syneos Health Japan K.K.
Division name
Real World Research
Zip code
100-7012
Address
JP Tower 12F, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-6733-9690
Homepage URL
xiaohe.tang@syneoshealth.com
Sponsor or person
Institute
Philip Morris Products S.A.
Institute
Department
Personal name
Funding Source
Organization
Philip Morris Products S.A.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Switzerland
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Health Research Foundation, The Ethics Review Committee for Research on Human Subjects
Address
Nishi-waseda 1-1-7, Shinjuku-ku, Tokyo, Japan
Tel
03-5287-5070
rinri@phrf.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 | 07 | Month | 21 | 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 | 05 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 26 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 14 | Day |
Other
Other related information
Factors to be considered:
This study will include adult TNP users and their adult relatives living in Japan. Aside from evaluating the measurement properties of the questionnaires, the extent to which age, years of TNP use by adult TNP users, relationship between adult TNP users and their adult relatives, and the degree to which adult relatives are aware of TNP use of adult TNP users influence the measurement properties of the questionnaires will also be assessed and reported.
Results on measurement properties:
1) Measures of reliability (test-retest reliability) will be reported: high consistency of responses to the same question by the same adult participant over a short period of time (approximately one week) demonstrates reliability of the questionnaire.
2) Measures of convergent validity (agreement) will be reported: a strong agreement between responses of adult TNP users and their adult relatives show high validity of the questionnaires.
Management information
Registered date
| 2025 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066895
