Breast Cancer FemalesNCT07434817
Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment
A study testing Sexual Health Educational Video Series in people with Breast Cancer Females and Newly Diagnosed Breast Cancer, run by University of Colorado, Denver at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Females, Newly Diagnosed Breast Cancer
- What is being tested?
- Sexual Health Educational Video Series
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Aug 2026to Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Sarah Leslie, MPH, Sarah.Leslie@cuanschutz.edu
Sarah Tevis, MD
- Recruiting
Denver Health Hospital and Clinic
Denver, Colorado, 80204
Sarah Leslie, MPH, Sarah.Leslie@cuanschutz.edu
Sarah Tevis, MD
- Recruiting
UCHealth Cherry Creek Medical Center
Denver, Colorado, 80206
Sarah Leslie, MPH, Sarah.Leslie@cuanschutz.edu
Sarah Tevis, MD
- Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Sarah Leslie, MPH, Sarah.Leslie@cuanschutz.edu
Sarah Tevis, MD
About this study
Official title: 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.
- Being tested
- Sexual Health Educational Video Series, Standard Care (in control arm)
- Keywords
- English and Spanish Speaking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Health Educational Video SeriesBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants receive access to the sexual-health educational video series. Receives: Behavioral: Sexual Health Educational Video Series |
| Control Arm | Placebo comparator | Participants receive standard care Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 2 months, 4 months, 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: One time, 60 minute interview, 6-12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start14 Aug 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer League of Colorado
- Responsible party
- Sponsor
- Investigators
- Sarah Tevis, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434817
- Sponsor's protocol ID
- 25-2154.cc
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No