UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039087 |
|---|---|
| Receipt number | 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 21:41:08 |
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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
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
sugitaniyso@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
-
-
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044571
