Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
93 participants
OBSERVATIONAL
2020-12-01
2025-10-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stage 0
Ductal carcinoma in situ. Timing: start of endocrine therapy
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
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
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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Sarah Tevis
Role: PRINCIPAL_INVESTIGATOR
Colorado Research Center
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Countries
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Other Identifiers
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NCI-2021-10894
Identifier Type: OTHER
Identifier Source: secondary_id
20-1789.cc
Identifier Type: -
Identifier Source: org_study_id
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