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A randomized controlled trial of the effect of RESPECT therapy for fertility preservation among young adult unmarried women with breast caner: REcovery and Shared-decision-making by Psychological Empowerment Counseling Team

A randomized controlled trial of the effect of RESPECT therapy for fertility preservation among young adult unmarried women with breast caner: REcovery and Shared-decision-making by Psychological Empowerment Counseling Team - RESPECT trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034218
Enrollment
200
Registered
2018-09-20
Start date
2018-09-20
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

breast cancer

Interventions

A course (intervention group): participating in RESPECT therapy twice per 30 days before cancer treatment B course (waiting control group): only participating in RESPECT therapy after cancer treatment

Sponsors

St. Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Newly diagnosed non-metastatic breast cancer. 2) Women aged 20 to 39 years old. 3) Must be legally unmarried. 4) Must be the patients of Division of Breast Surgery, Department of Surgery, and/or Division of reproduction, Department of Obstetrics and Gynecology, which are in member of the RESPECT trials. 5) Must have at least 4 days between informed consent date and cancer treatment beginning date.

Exclusion criteria

Exclusion criteria: 1) Refuse to sign the informed consent agreement. 2) Unable to fill in written questionnaires on their own (having severe physical incapacity, or psychiatric illnesses such as schizophrenia, or low literacy, or mental retardation). 3) Within three days between informed consent date and cancer treatment beginning date.

Design outcomes

Primary

MeasureTime frame
PTSD symptoms (IES-R-J) at the time between after intervention and before cancer treatment

Secondary

MeasureTime frame
Mini Mental Adjustment to Cancer Scale (Mini-MAC) and Decisional Conflict Scale at the time between after intervention and before cancer treatment

Countries

Japan

Contacts

Public ContactNao Suzuki

St. Marianna University School of Medicine Department of Obstetrics and Gynecology

nao@marianna-u.ac.jp044-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026