UMIN-CTR Clinical Trial

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037445
Receipt No. 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 (Ver. 1)

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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
Email 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/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041687