UMIN-CTR Clinical Trial

Basic information
Public title	A study to identify factors that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire
Acronym	A study to identify factor that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire(SELECT BC-CONFIRM-FEEL 2)
Scientific Title	A study to identify factors that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire
Scientific Title:Acronym	A study to identify factor that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire(SELECT BC-CONFIRM-FEEL 2)
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify factors that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire at the time when we ask them to participate in the trial, SELECT BC-CONFIRM. Then we use the information to make the patients' entry more efficient in our future clinical trials.
Basic objectives2	Others
Basic objectives -Others	Obtain information that can contribute to informed consent in the planning and clinical practice of the future of the clinical trial
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	a comprehensive evaluation of factors that affect the "participation and refusal of the decision-making to the trial, SELECT BC-CONFIRM" with calculation of odds ratios, stratified analysis and multivariate analysis.
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	75 years-old >=
Gender	Female
Key inclusion criteria	This was carried out as accompanying study of SELECT BC-CONFIRM which was a randomized controlled study conducted in metastatic or recurrent breast cancer patients. Eligible patients were all of those who were asked to participate in SELECT BC-CONFIRM.
Key exclusion criteria	According to the SELECT BC-CONFIRM.
Target sample size	177

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shozo Ohsumi
Organization	NHO Shikoku Cancer Center
Division name	Department of Breast Oncology
Zip code
Address	160 Kou, Minamiumemoto-machi,Matsuyama City, Ehime Prefecture,Japan
TEL	+81-(0)89-999-1111
Email	sosumi@shikoku-cc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Akira Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Clinical Research
Zip code
Address	Nishiwaseda1-1-7, Shinjyuku-ku Tokyo, 169 -0051 Japan
TEL	03-5287-2636
Homepage URL	http://www.csp.or.jp/
Email	cspor-office@csp.or.jp

Sponsor
Institute	SELECT BC-CONFIRM executive committee
Institute
Department

Funding Source
Organization	Public Health Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
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	2016 Year 02 Month 29 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	Completed
Date of protocol fixation	2011 Year 03 Month 01 Day
Date of IRB	2011 Year 05 Month 18 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2014 Year 01 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We handed a self-administered questionnaire to all study candidated. SELECT BC-CONFIRM trial UMIN ID :000005449

Management information
Registered date	2016 Year 02 Month 29 Day
Last modified on	2021 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024506