An observational study in Breast Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by University of Colorado, Denver · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 93 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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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.
Exclusion Criteria:
Ductal carcinoma in situ. Timing: start of endocrine therapy
Behavioral: Focus Group
Invasive cancer. Surgery first Timing: start of endocrine therapy
Behavioral: Focus Group
Invasive cancer. Neoadjuvant chemotherapy first Timing: during neoadjuvant chemotherapy
Behavioral: Focus Group
Metastatic cancer, chemotherapy only, no invasive surgery Timing: 2 months into treatment
Behavioral: Focus Group
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.
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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 1 year
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver