UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056384 |
|---|---|
| Receipt number | R000064421 |
| Scientific Title | Systemic treatment preference study of patients with non-small cell lung cancer and exploring patients' and caregivers' burden |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2024/12/06 22:39:55 |
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Basic information
Public title
Systemic treatment preference study of patients with non-small cell lung cancer and exploring patients' and caregivers' burden
Acronym
Treatment preferences of patients of non-small cell lung cancer and exploring patients' and caregivers' burden
Scientific Title
Systemic treatment preference study of patients with non-small cell lung cancer and exploring patients' and caregivers' burden
Scientific Title:Acronym
Treatment preferences of patients of non-small cell lung cancer and exploring patients' and caregivers' burden
Region
| Japan |
Condition
Condition
Non-small cell lung cancer: NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To understand the differences in treatment attribute preferences of patients with NSCLC
To understand the characteristics and burden of caregivers of patients with NSCLC
Basic objectives2
Others
Basic objectives -Others
Treatment preference
Disease burden
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
For patients:
Treatment preferences: treatment effectiveness including side effects.
For caregivers:
The burden of NSCLC patient's care.
Key secondary outcomes
Exploration of the burden on patients with NSCLC
Examination of patient preferences for different pharmacological treatment attributes
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
| 94 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients
Individuals who meet the following criteria (1 and 2 or 1 and 3) will be included in the study.
1.Patients who are 18-94 years old
2.Patients who were initially diagnosed as NSCLC at stage IV (self-reported)
3.Patients who are experiencing or have experienced systemic treatments (self-reported)
(In qualitative study, patients diagnosed as NSCLC at stage IIIa/b/c as well as stage IV can be allowed in case of limited recruitment availability in the patient panel for the above inclusion criteria.)
Caregivers
Individuals who meet all the following criteria will be included in the study.
- Caregivers who are 18-94 years old
- Caregivers who are currently caring for an NSCLC patient
- Primary caregiver (mainly responsible or sharing responsibility equally for making treatment decisions and managing finances)
Key exclusion criteria
There are not exclusion criteria in this study.
Target sample size
474
Research contact person
Name of lead principal investigator
| 1st name | Tatsuki |
| Middle name | |
| Last name | Ishizuka |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Health Economics and Outcomes Research group, HCA strategy dept., Market Access and Healthcare Affairs
Zip code
141-0032
Address
Think Park Tower 2-1-1 Shinagawa-ku, Tokyo
TEL
03-6683-7232
tatsuki.ishizuka@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Tatsuki |
| Middle name | |
| Last name | Ishizuka |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Health Economics and Outcomes Research grp, HCA strategy dept, Market Access and Healthcare Affairs
Zip code
141-0032
Address
Think Park Tower 2-1-1 Shinagawa-ku, Tokyo
TEL
03-6683-7232
Homepage URL
tatsuki.ishizuka@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
0364161868
npo-mins@j-irb.com
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
| 2024 | Year | 12 | Month | 06 | 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
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-interventional study
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064421
