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| Name | Class |
|---|---|
| Cancer League of Colorado | OTHER |
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Approximately 200 English- or Spanish-speaking women newly diagnosed with stage I-III breast cancer will be randomized to either receive access to an online sexual health video series or receive usual care. Participants will complete surveys at baseline and every two months for six months, measuring self-efficacy in patient-provider communication and perceived barriers to discussing sexual health. Electronic health record review will assess utilization of sexual-health-related medical and supportive services. A subset of participants will participate in qualitative interviews to explore their sexual health experiences during treatment and, for those receiving the intervention, the perceived impact of the videos.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants receive access to the sexual-health educational video series. |
|
| Control Arm | Placebo Comparator | Participants receive standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sexual Health Educational Video Series | Behavioral | Participants randomized to the intervention arm will receive multiprong access to the videos, including a link provided through email and the recruitment sites' patients portal, a QR code, and tablets available in each clinic. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant self-efficacy discussing sexual health with breast cancer providers | Changes in participant self-efficacy to discuss sexual health with breast cancer providers will be assessed using the Perceived Efficacy in Patient-Physician Interactions (PEPPI-5), administered at enrollment and every two months over a six-month period. The PEPPI-5 is a 5-item measure scored on a 5-point Likert scale, with higher scores indicating greater perceived self-efficacy in communicating with healthcare providers. | Baseline, 2 months, 4 months, 6 months |
| Perceived barriers to discussing sexual health with breast cancer providers | Measured using the 13-item Barriers to Sexual Health Communication (BSHC) scale. Items are rated on a 5-point Likert scale; higher scores reflect greater perceived communication barriers. | Baseline, 2 months, 4 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Use of medical and supportive services outside of treatment-plan related visits | Participant use of medical and supportive services outside of treatment-plan-related visits will be assessed through electronic health record review from enrollment through 12 months of follow-up. Services of interest will include supportive care, behavioral health, sexual health, rehabilitation, and other ancillary services. Self-reported data collected at enrollment will capture utilization of relevant medical and supportive services in the period prior to study participation. |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility is restricted to individuals whose sex assigned at birth is female, as the study intervention and outcomes pertain specifically to sexual health experiences during breast cancer treatment in female patients.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Leslie, MPH | Contact | 303-724-8995 | Sarah.Leslie@cuanschutz.edu | |
| Sarah Tevis, MD | Contact | 303-724-2750 | sarah.tevis@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Tevis | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| Standard Care (in control arm) | Other | Standard Care |
|
| 12 months |
| Qualitative measure: Patient-reported experiences with sexual health and perceived impact of the video content. | Patient sexual health will be assessed qualitatively through semi-structured interviews with a subset of participants at six months following breast cancer diagnosis. Interviews will explore participants' experiences with sexual health concerns and evaluate how the video content did or did not influence their knowledge, communication, coping, and perceived support related to sexual health during treatment and survivorship. | One time, 60 minute interview, 6-12 months after enrollment |
| Denver Health Hospital and Clinic | Denver | Colorado | 80204 | United States |
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| UCHealth Cherry Creek Medical Center | Denver | Colorado | 80206 | United States |
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| UCHealth Highlands Ranch Hospital | Highlands Ranch | Colorado | 80129 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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