Clinical Trial: Quantitative Validation of Questionnaires on Use of Tobacco and Nicotine Containing Products from the Perspectives of Adult Users and Their Adult Relatives in Japan (Japan)

Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058508) titled 'Quantitative Validation of Questionnaires on Use of Tobacco and Nicotine Containing Products from the Perspectives of Adult Users and Their Adult Relatives in Japan' on July 21.

Study Type: Observational

Primary Sponsor: Institute - Philip Morris Products S.A.

Condition: Condition - Healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 18 years-old =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 Size - 200

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066895

Disclaimer: Curated by HT Syndication.