Sexual Health in Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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. 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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Focus Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |