NCT07434817 · University of Colorado, Denver
Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment
What this study is about
Approximately 200 English- or Spanish-speaking women newly diagnosed with stage I-III breast cancer will be randomly assigned to either receive access to an online sexual health video series or receive usual care.
View original scientific description
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.
Interventions
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.
OTHER
Standard Care (in control arm)
Standard Care
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
- Denver, Colorado
- Highlands Ranch, Colorado
Collaborators
Cancer League of Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2026 · Source of record for eligibility and locations