Sexual Coercion in Breast Cancer Patients Treated With Luteinizing Hormone-Releasing Hormone Agonists (LHRHa ) (LHRHa)

February 21, 2025 updated by: Canan Kas
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: 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.

Methods: This study is a randomized controlled study. In this study, the validated Turkish version of the Sexual Coercion in Intimate Relationship Scale was utilized to investigate whether patients receiving LHRHa therapy experienced higher rates of sexual sexual coercion compared to those taking tamoxifen. The study included 40 patients using LHRHa and 39 patients using tamoxifen. The instrument assessed partner sexual coercion across three subdomains: resource manipulation/sexual coercion, commitment manipulation, and defection threat.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Kastamonu, Merkez, Turkey, 37150
        • Kastamonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LHRHa
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
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.
Active Comparator: Tamoxifen (Nolvadex)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LHRHa
Time Frame: for 10 months
It was examined whether patients receiving LHRHa treatment were exposed to sexual pressure.
for 10 months
Tamoxifen
Time Frame: for 10 months
It was examined whether patients receiving tamoxifen treatment were exposed to sexual pressure.
for 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canan Kas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 29, 2024

Study Registration Dates

First Submitted

February 1, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KAEK-148
  • Kastamonu Universty 2023/148 (Other Grant/Funding Number: Kastamonu Universty)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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