NCT06840847

Brief Summary

The use of luteinizing hormone-releasing hormone agonists(LHRHa) to suppress ovarian function is a common strategy for treating premenopausal, hormone receptor-positive breast cancer. However, this approach can lead to more severe and prolonged menopausal symptoms, which can further impact intimate relationships and sexual function. Sexual coercion, encompassing both overt and subtle forms of pressure, is a significant global public health concern that threatens individual well-being.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

February 1, 2025

Last Update Submit

February 21, 2025

Conditions

Keywords

breast cancer

Outcome Measures

Primary Outcomes (2)

  • LHRHa

    It was examined whether patients receiving LHRHa treatment were exposed to sexual pressure.

    for 10 months

  • Tamoxifen

    It was examined whether patients receiving tamoxifen treatment were exposed to sexual pressure.

    for 10 months

Study Arms (2)

LHRHa

ACTIVE COMPARATOR

In this study, included 40 patients on LHRHa. The instrument assessed partner sexual coercion in three domains: resource manipulation/sexual coercion, commitment manipulation, and threat of separation.

Behavioral: Sexual Coercion

Tamoxifen (Nolvadex)

ACTIVE COMPARATOR

In this study included 39 patients on tamoxifen. The instrument assessed partner sexual coercion in three domains: resource manipulation/sexual coercion, commitment manipulation, and threat of separation.

Behavioral: Sexual Coercion

Interventions

Sexual CoercionBEHAVIORAL

This study aimed to investigate whether patients receiving LHRHa treatment experienced sexual coercion at a higher rate than those using tamoxifen. 40 patients using LHRHa and 39 patients using tamoxifen were included in the study.

LHRHaTamoxifen (Nolvadex)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • being over 18 years of age
  • willingness to participate in this study
  • having received treatment for breast cancer
  • having a history of breast cancer surgery
  • having an active relationship with a spouse or partner.

You may not qualify if:

  • having any neuropsychiatric disorder
  • having any mental illness
  • having a history of gynecological surgery
  • currently receiving active chemotherapy or less than 3 months since completing chemotherapy
  • receiving treatment for metastatic disease
  • The use of selective serotonin reuptake inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu University

Kastamonu, Merkez, 37150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, MSc, RN, Assistant Professor

Study Record Dates

First Submitted

February 1, 2025

First Posted

February 21, 2025

Study Start

January 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 29, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations