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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000039087
Receipt No. R000044571
Scientific Title The study of Japanese lung cancer patients' preferences using data from discrete choice experiment
Date of disclosure of the study information 2020/01/10
Last modified on 2021/07/23

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Basic information
Public title The study of Japanese lung cancer patients' preferences using data from discrete choice experiment
Acronym The study of Japanese lung cancer patients' preferences using data from discrete choice experiment
Scientific Title The study of Japanese lung cancer patients' preferences using data from discrete choice experiment
Scientific Title:Acronym The study of Japanese lung cancer patients' preferences using data from discrete choice experiment
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 By using the dataset of discrete choice experiment about drug therapy for Japanese lung cancer patients, to clarify important attributes, relation between patients demographics and preferences, and limitation of preference elicitation methodology.
Basic objectives2 Others
Basic objectives -Others A retrospective analysis for secondary use of online survey
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes relative importance of attributes and levels of drug therapy
Key secondary outcomes relation between patients' demographics and relative importance of attributes and levels of drug therapy

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)respondent of online survey from 25 November 2019 to 27 November 2019.
2) Lung cancer patients
Key exclusion criteria N/A
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Sugitani
Organization Chugai pharmaceutical Co., Ltd.
Division name Clinical Development Div.
Zip code 103-8324
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku, Tokyo, Japan
TEL 03-3273-0934
Email sugitaniyso@chugai-pharm.co.jp

Public contact
Name of contact person
1st name Yasuo
Middle name
Last name Sugitani
Organization Chugai pharmaceutical Co., Ltd.
Division name Clinical Development Div.
Zip code 103-8324
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku, Tokyo, Japan
TEL 03-3273-0934
Homepage URL
Email sugitaniyso@chugai-pharm.co.jp

Sponsor
Institute Chugai pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Chugai pharmaceutical Co., Ltd.
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 Ethical Review Committee (Japanese Ministry of Health, Labour and Welfare's No. 11001028)
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku, Tokyo, Japan
Tel -
Email -

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
2020 Year 01 Month 10 Day

Related information
URL releasing protocol N/A
Publication of results Published

Result
URL related to results and publications https://www.frontiersin.org/articles/10.3389/fphar.2021.697711/full
Number of participants that the trial has enrolled 200
Results In Japanese lung cancer patients' preference, OS was the most important, followed by diarrhea, nausea, rash, bone marrow suppression, PFS, fatigue, interstitial lung disease, frequency of administration, and duration of administration. The preferences were influenced by demographic characteristics and disease background. Interestingly, the experience of cancer drug therapies and adverse events had a substantial impact on the hypothetical drug preferences.
Results date posted
2021 Year 07 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 07 Month 20 Day
Baseline Characteristics Of the total 200 respondents, 191 were included in the subsequent analysis, excluding the nine unreliable respondents who chose the same option for all questions. The proportion of males was 82.7% (158/191), which was considerably higher than in previous studies. The mean age was 63.3 years, similar to that reported in previous studies. Most of the patients were in the early lung cancer stage, with 82 patients (42.9%) in Stage I.
Participant flow An anonymous web-based questionnaire with a reward was administered from November 25, 2019, to November 27, 2019. Out of the 448 lung cancer patients in the panel held by Rakuten Insight, Inc., 200 people were enrolled in our study.

Prospective participants were informed that they needed to be lung cancer patients to participate in the study. Lung cancer diagnosis was based on the participant's self-report, and no medical diagnosis was made to confirm the condition.
Adverse events N/A
Outcome measures The relative importance of patient preferences for each attribute as the main effects estimated by the conditional logit model is below. An increase in OS from 10 to 20 months was the most important attribute, followed by an increase in OS from 10 to 15 months and an increase in the occurrence of diarrhea (from 50 to 100%), nausea (from 10 to 50%), rash (from 10 to 80%), and BMS (from 0 to 20%). An increase in PFS from 4 to 9 months was the least important benefit attribute, similar to an increase in fatigue (from 10 to 30%), ILD (from 0 to 5%), and frequency and duration of administration.
Plan to share IPD The datasets analyzed for this study are not publicly available because they contain information that could compromise respondents' privacy and consent.
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2019 Year 12 Month 04 Day
Date of IRB
2019 Year 12 Month 16 Day
Anticipated trial start date
2020 Year 01 Month 04 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 07 Month 20 Day

Other
Other related information A retrospective analysis of secondary using of online survey

Management information
Registered date
2020 Year 01 Month 08 Day
Last modified on
2021 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044571

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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