Skip to main content
OpenTrials
Completed

NCT Number: NCT05138510

Sexual Health in Breast Cancer Patients

In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment. The objectives are as follows:

  • To characterize the sexual well-being of women longitudinally throughout the continuum of care, from initial diagnosis into survivorship.

We predict that treatment will adversely affect sexual well-being, and that patient factors, clinical factors, and treatment choices will influence changes in sexual well-being.

  • To identify gaps is sexual health education provided at the time of diagnosis or during treatment and to determine the appropriate timing of sexual health education delivery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 09/01/2019 to present, will potentially be recruited to participate.

Exclusion criteria

  • Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.

Treatment and study plan

Focus Group

Behavioral

Providers with extensive training and expertise in the subject will lead the virtual focus groups over Zoom using a semi-structured guide. Topics will focus on education received from the health care team, information received from outside sources, and patient recommendations on the type and timing of information preferred.

We will create an analytic report based on the focus group findings, which will be used to inform the development of educational material.

Sexual well-being is currently measured longitudinally on a 0-100 point scale as a component of a validated patient-reported outcome measures (PROM) survey (BREAST-Q) distributed to all breast cancer patients. These scores will be analyzed in patients with and without educational interventions for comparison.

Primary outcomes

  1. Determine changes in sexual well-being for women with breast cancer

    Time frame: 1 year

    Determine changes in sexual well-being throughout the course of breast cancer treatment, pre- and post-implementation of developed educational materials using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey

  2. Determine educational resources currently used for sexual health information

    Time frame: 1 year

    Determine patients' self reported list of educational media received regarding sexual health during breast cancer treatment using the PROM survey (BREAST-Q)

  3. Determine educational resources currently used for sexual health information

    Time frame: 1 year

    Determine patients' self reported list of educational media received regarding sexual health during breast cancer treatment using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey

  4. Determine patients preferred type of education for sexual health

    Time frame: 1 year

    Determine the patients preferred type and timing of educational interventions for sexual health using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Sexuality and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2021
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.