Sexual Health in Breast Cancer Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Focus Group

Detailed Description

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:

1. 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.

2. 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Victoria Huynh; Phone Number: 8327202162; Email: victoria.d.huynh@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Victoria Huynh, MD
      • Contact: Phone Number: 8327202162
      • Sub-Investigator: Anosheh Afghahi
      • Sub-Investigator: Victoria Huynh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 9/1/2019 to present, will potentially be recruited to participate. Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage 0; Ductal carcinoma in situ. Timing: start of endocrine therapy	Behavioral: Focus Group; 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.
Stages I-III Surgery first; Invasive cancer. Surgery first Timing: start of endocrine therapy	Behavioral: Focus Group; 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.
Stages I-III, neoadjuvant chemotherapy first; Invasive cancer. Neoadjuvant chemotherapy first Timing: during neoadjuvant chemotherapy	Behavioral: Focus Group; 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.
Stage IV; Metastatic cancer, chemotherapy only, no invasive surgery Timing: 2 months into treatment	Behavioral: Focus Group; 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.
Survivors; Timing: any time	Behavioral: Focus Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine changes in sexual well-being for women with breast cancer	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	1 year
Determine educational resources currently used for sexual health information	Determine patients' self reported list of educational media received regarding sexual health during breast cancer treatment using the PROM survey (BREAST-Q)	1 year
Determine educational resources currently used for sexual health information	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	1 year
Determine patients preferred type of education for sexual health	Determine the patients preferred type and timing of educational interventions for sexual health using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey	1 year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Sarah Tevis, Colorado Research Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20-1789.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data will not be shared with other researchers. Individual Participant Data will be housed in a deidentified format in the secure, encrypted REDCap database of the University of Colorado School od Medicine.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No