UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study to explore psychological status and quality of life in patients with hereditary breast and ovarian cancer
Acronym	MentaQ trial
Scientific Title	A prospective observational study to explore the impact of risk-reducing mastectomy and surveillance on mental and psychological status and quality of life in patients with hereditary breast and ovarian cancer
Scientific Title:Acronym	MentaQ trial
Region	Japan

Condition
Condition	Hereditary breast and ovarian cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To clarify the medium- to long-term changes in mental and psychological status and quality of life from the disclosure of BRCA genetic test results to the decision to choose of risk reduction strategies and the implementation of surveillance or risk-reducing mastectomy.
Basic objectives2	Others
Basic objectives -Others	Supporting decision-making for risk reduction strategies in patients with hereditary breast and ovarian cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Chronological changes in PHQ-9 scores
Key secondary outcomes	1) Chronological changes in GAD-7 scores 2) Chronological changes in SF-36 scores 3) Clinical background factors and their relevance to decision making on risk reduction strategies

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	Not applicable
Gender	Female
Key inclusion criteria	1) Women who have developed breast or ovarian cancer with a pathological variant of BRCA1 or BRCA2 confirmed by BRCA genetic testing 2) Patients scheduled for risk-reducing mastectomy or imaging surveillance including contrast-enhanced MRI as a risk reduction strategy (with or without risk-reducing salpingo-oophorectomy) 3) Women over 20 years old
Key exclusion criteria	1) Bilateral breast cancer patients 2) Patients with metastasis or recurrence 3) Patients with active multiple primary cancers 4) Patients with contraindications to MRI examinations and the use of contrast media 5) Patients deemed inappropriate by the physician in charge of treatment
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Rurina Middle name Last name Watanuki
Organization	National Cancer Center Hospital East
Division name	Department of Breast Surgery
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577 Japan
TEL	04-7133-1111
Email	rwatanuk@east.ncc.go.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Onishi
Organization	National Cancer Center Hospital East
Division name	Department of Breast Surgery
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577 Japan
TEL	04-7133-1111
Homepage URL
Email	taonishi@east.ncc.go.jp

Sponsor
Institute	Department of Breast Surgery, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	None
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	National Cancer Center Hospital East Certified Review Board
Address	6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577 Japan
Tel	04-7133-1111
Email	ncche-irb@east.ncc.go.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	国立がん研究センター東病院

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 03 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	2021 Year 11 Month 02 Day
Date of IRB	2021 Year 11 Month 02 Day
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2030 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Assessment of mental and psychological status and quality of life over time using a questionnaire from the time of diagnosis of hereditary breast and ovarian cancer by BRCA genetic testing

Management information
Registered date	2022 Year 03 Month 03 Day
Last modified on	2022 Year 03 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053691