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

February 25, 2026 updated by: University of Colorado, Denver

Improving Breast Cancer Patients' Self-Efficacy and Sexual Health Quality of Life

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
        • Principal Investigator:
          • Sarah Tevis, MD
        • Contact:
      • Denver, Colorado, United States, 80206
        • UCHealth Cherry Creek Medical Center
        • Principal Investigator:
          • Sarah Tevis, MD
        • Contact:
      • Denver, Colorado, United States, 80204
        • Denver Health Hospital and Clinic
        • Principal Investigator:
          • Sarah Tevis, MD
        • Contact:
      • Highlands Ranch, Colorado, United States, 80129
        • UCHealth Highlands Ranch Hospital
        • Principal Investigator:
          • Sarah Tevis, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Participants receive access to the sexual-health educational video series.
Behavioral: 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.
Placebo Comparator: Control Arm
Participants receive standard care
Other: Standard Care (in control arm)
Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant self-efficacy discussing sexual health with breast cancer providers
Time Frame: Baseline, 2 months, 4 months, 6 months
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
Time Frame: Baseline, 2 months, 4 months, 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of medical and supportive services outside of treatment-plan related visits
Time Frame: 12 months
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.
12 months
Qualitative measure: Patient-reported experiences with sexual health and perceived impact of the video content.
Time Frame: One time, 60 minute interview, 6-12 months after enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Cancer League of Colorado

Investigators

  • Principal Investigator: Sarah Tevis, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-2154.cc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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