Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07434817
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Females
  • Newly Diagnosed Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Standard Care (in control arm) — OTHER
    Standard Care

Study Details

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.

Key Dates

Start date
Jan 31, 2027
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Arm
    Participants receive access to the sexual-health educational video series.
  • Placebo Comparator: Control Arm
    Participants receive standard care

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Sarah Leslie, MPH
[email protected]
Sarah Tevis, MD (PRINCIPAL_INVESTIGATOR)
Denver Health Hospital and ClinicDenverColorado80204
Sarah Leslie, MPH
[email protected]
Sarah Tevis, MD (PRINCIPAL_INVESTIGATOR)
UCHealth Cherry Creek Medical CenterDenverColorado80206
Sarah Leslie, MPH
[email protected]
Sarah Tevis, MD (PRINCIPAL_INVESTIGATOR)
UCHealth Highlands Ranch HospitalHighlands RanchColorado80129
Sarah Leslie, MPH
[email protected]
Sarah Tevis, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital· Aurora, CODenver Health Hospital and Clinic· Denver, COUCHealth Cherry Creek Medical Center· Denver, COUCHealth Highlands Ranch Hospital· Highlands Ranch, CO