Sexual Health in Breast Cancer Patients

Recruiting

• Conditions: Breast Cancer
• Interventions: Behavioral: Focus Group

• Registration Number: NCT05138510
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Determine educational resources currently used for sexual health information	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
Determine changes in sexual well-being for women with breast cancer	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
Determine patients preferred type of education for sexual health	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

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States