Sexual Health in Breast Cancer Patients

NCT05138510 | Completed

• 2 other identifiers: 20-1789.ccNCI-2021-10894
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

Stage 0

Ductal carcinoma in situ. Timing: start of endocrine therapy

Behavioral: Focus Group

Stages I-III Surgery first

Invasive cancer. Surgery first Timing: start of endocrine therapy

Behavioral: Focus Group

Stages I-III, neoadjuvant chemotherapy first

Invasive cancer. Neoadjuvant chemotherapy first Timing: during neoadjuvant chemotherapy

Behavioral: Focus Group

Stage IV

Metastatic cancer, chemotherapy only, no invasive surgery Timing: 2 months into treatment

Behavioral: Focus Group

Survivors

Timing: any time

Behavioral: Focus Group

Interventions

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.

Stage 0; Stage IV; Stages I-III Surgery first; Stages I-III, neoadjuvant chemotherapy first; Survivors

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sarah Tevis

  Colorado Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2020
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)