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

NCT07434817 | Not Yet Recruiting DMC

• 1 other identifier: 25-2154.cc
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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

Keywords

English and Spanish Speaking

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Use of medical and supportive services outside of treatment-plan related visits

  12 months

• Qualitative measure: Patient-reported experiences with sexual health and perceived impact of the video content.

  One time, 60 minute interview, 6-12 months after enrollment

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Behavioral: Sexual Health Educational Video Series

Control Arm

PLACEBO COMPARATOR

Participants receive standard care

Other: Standard Care (in control arm)

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.

Intervention Arm

Standard Care (in control arm) OTHER

Standard Care

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cancer League of Colorado: collaborator

Study Sites (4)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Denver Health Hospital and Clinic

Denver, Colorado, 80204, United States

Location

UCHealth Cherry Creek Medical Center

Denver, Colorado, 80206, United States

Location

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarah Tevis

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Leslie, MPH

CONTACT

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

Sarah Tevis, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (4)