UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037445 |
|---|---|
| Receipt number | R000041687 |
| Scientific Title | Estimation of Willingness-to-Pay for breast cancer treatments through Contingent Valuation Method in Japanese breast cancer patients: JCOG1709A |
| Date of disclosure of the study information | 2019/07/22 |
| Last modified on | 2019/07/22 10:02:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Estimation of Willingness-to-Pay for breast cancer treatments through Contingent Valuation Method in Japanese breast cancer patients(JCOG1709A)
Acronym
Estimation of Willingness-to-Pay for breast cancer treatments through Contingent Valuation Method in Japanese breast cancer patients(JCOG1709A)
Scientific Title
Estimation of Willingness-to-Pay for breast cancer treatments through
Contingent Valuation Method in Japanese breast cancer patients: JCOG1709A
Scientific Title:Acronym
JCOG1709A
Region
| Japan |
Condition
Condition
1)Unilateral breast cancer patients who fulfill either i) or ii) below
i)Primary breast cancer of clinical stage 0 through III for which surgery and /or chemotherapy and / or radiotherapy has been completed as initial treatment and that is currently undergoing regular follow-up observations or postoperative endocrine therapy
ii) Undergoing endocrine therapy or first-line through third-line chemotherapy for metastatic or recurrent cancer for at least 2 months
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prove how Japanese breast cancer patients who received treatment in Japan consider the financial value (willingness to pay; WTP) for their life and health by using the contingent valuation method (CVM), prospectively. Based on our results, we will construct an evaluation axis from patients' viewpoint for the cost effectiveness of clinical trials to establish standard treatments for breast cancer.
Basic objectives2
Others
Basic objectives -Others
Prospective observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
WTP for hypothetical scenarios
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Unilateral breast cancer patients who fulfill either i) or ii) below
i)Primary breast cancer of clinical stage 0 through III for which surgery and/ or chemotherapy and / or radiotherapy has been completed as initial treatment and that is currently undergoing regular follow-up observations or postoperative endocrine therapy
ii)Undergoing endocrine therapy or first-line through third-line chemotherapy for metastatic or recurrent cancer at least 2 months
2)Woman aged 20 - 79 years at the date of registration
3)No history of malignant tumor except forbreast cancer
4)No difficulty in reading and writing in Japanese
5)Have a copayment for medical fees (any copayment ratio allowed)
6)Not being administered a trial drug
7)Not a student
8)Written informed consent
Key exclusion criteria
Nothing
Target sample size
1764
Research contact person
Name of lead principal investigator
| 1st name | Hiroji |
| Middle name | |
| Last name | Iwata |
Organization
Aichi Cancer Center Hospital
Division name
Department of Breast Oncology
Zip code
464-8681
Address
1-1 Kanakoden, Chikusa-ku, Nagoya-shi, Aichi prefecture, Japan, 464-8681
TEL
052-762-6111
JCOG_sir@ml.jcog.jp
Public contact
Name of contact person
| 1st name | Tsuguo |
| Middle name | |
| Last name | Iwatani |
Organization
JCOG1709A Coordinating Office
Division name
Department of Breast Surgery, National Cancer Center Hospital East
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan
TEL
04-7133-1111
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel
052-762-6111
irb@aichi-cc.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
国立病院機構北海道がんセンター（北海道）
岩手医科大学（岩手県）
東北大学病院（宮城県）
福島県立医科大学附属病院（福島県）
筑波大学医学医療系（茨城県）
自治医科大学（栃木県）
群馬県立がんセンター（群馬県）
埼玉県立がんセンター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
がん・感染症センター都立駒込病院（東京都）
国立病院機構東京医療センター（東京都）
昭和大学病院（東京都）
がん研究会有明病院（東京都）
虎の門病院（東京都）
聖路加国際病院（東京都）
東海大学医学部（神奈川県）
聖マリアンナ医科大学（神奈川県）
神奈川県立がんセンター（神奈川県）
北里大学医学部（神奈川県）
横浜労災病院（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
静岡県立総合病院（静岡県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構名古屋医療センター（愛知県）
名古屋市立大学病院（愛知県）
近畿大学医学部（大阪府）
大阪国際がんセンター（大阪府）
国立病院機構大阪医療センター（大阪府）
岡山大学病院（岡山県）
国立病院機構呉医療センター・中国がんセンター（広島県）
広島大学病院（広島県）
広島市立広島市民病院（広島県）
国立病院機構福山医療センター（広島県）
広島市立安佐市民病院（広島県）
国立病院機構四国がんセンター（愛媛県）
国立病院機構九州がんセンター（福岡県）
北九州市立医療センター（福岡県）
国立病院機構長崎医療センター（長崎県）
熊本大学医学部（熊本県）
博愛会相良病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to prove how Japanese breast cancer patients who received treatment in Japan consider the financial value (willingness to pay; WTP) for their life and health by using the contingent valuation method (CVM), prospectively. Based on our results, we will construct an evaluation axis from patients' viewpoint for the cost effectiveness of clinical trials to establish standard treatments for breast cancer.
Management information
Registered date
| 2019 | Year | 07 | Month | 22 | Day |
Last modified on
| 2019 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041687
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
