A prospective observational study to explore psychological status and quality of life in patients with hereditary breast and ovarian cancer

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 - MentaQ trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047067

Enrollment

100

Registered

2022-03-03

Start date

2022-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary breast and ovarian cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Chronological changes in PHQ-9 scores	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTatsuya Onishi

National Cancer Center Hospital East Department of Breast Surgery

taonishi@east.ncc.go.jp04-7133-1111

Outcome results