Recruiting

Sexual Health

Sponsor:

University of Colorado, Denver

Code:

NCT07434817

Conditions

Breast Cancer Females

Newly Diagnosed Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sexual Health Educational Video Series

Standard Care (in control arm)

Study Details

Brief summary:

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.

Conditions

Breast Cancer Females

Newly Diagnosed Breast Cancer

Study ID

NCT07434817

Start date

Aug 14, 2026

Status verified date

Oct, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision to sign and date the consent form.
  • Stated willingness to comply with all study procedures and be available for the duration of the study.
  • Age minimum 18
  • Be a female as assigned on birth certificate
  • Ability to read and speak English or Spanish
  • A recent diagnosis of Stage 1-III invasive breast cancer and receiving treatment for breast cancer at the University of Colorado or Denver Health breast center(s).

Exclusion Criteria:

  • Age less than 18 years old
  • Stage 0 or Stage IV breast cancer
  • Prior breast cancer diagnosis
  • Non-breast cancer diagnoses
  • Prior exposure to anti-hormone therapy, chemotherapy, or radiotherapy not related to breast cancer

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Participants receive access to the sexual-health educational video series.

placebo comparator: Control Arm

Participants receive standard care

Interventions

Sexual Health Educational Video Series

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.

Standard Care (in control arm)

Standard Care

Primary outcome measure

  • Participant self-efficacy discussing sexual health with breast cancer providers [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
  • Perceived barriers to discussing sexual health with breast cancer providers [ Time Frame: Baseline, 2 months, 4 months, 6 months ]

Central Contacts and Locations

Central contacts

Sarah Leslie, MPH

303-724-8995Sarah.Leslie@cuanschutz.edu

Sarah Tevis, MD

303-724-2750sarah.tevis@cuanschutz.edu

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sarah Leslie, MPH

Sarah.Leslie@cuanschutz.edu

Principal Investigator:

Sarah Tevis, MD

Denver Health Hospital and Clinic

Recruiting

Denver, Colorado, United States, 80204

Contacts

Sarah Leslie, MPH

Sarah.Leslie@cuanschutz.edu

Principal Investigator:

Sarah Tevis, MD

UCHealth Cherry Creek Medical Center

Recruiting

Denver, Colorado, United States, 80206

Contacts

Sarah Leslie, MPH

Sarah.Leslie@cuanschutz.edu

Principal Investigator:

Sarah Tevis, MD

UCHealth Highlands Ranch Hospital

Recruiting

Highlands Ranch, Colorado, United States, 80129

Contacts

Sarah Leslie, MPH

Sarah.Leslie@cuanschutz.edu

Principal Investigator:

Sarah Tevis, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • English and Spanish Speaking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.