Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sexual Health Educational Video Series, Standard Care (in control arm).
- Who it may be relevant to
- Registry conditions: Breast Cancer Females, Newly Diagnosed Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Breast Cancer Patients' Self-Efficacy and Sexual Health Quality of Life
Overview
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]
- Perceived barriers to discussing sexual health with breast cancer providers [Time frame: Baseline, 2 months, 4 months, 6 months]
Secondary outcome measures (2)
- Use of medical and supportive services outside of treatment-plan related visits [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 4 centers
- University of Colorado Hospital — Aurora
- Denver Health Hospital and Clinic — Denver
- UCHealth Cherry Creek Medical Center — Denver
- UCHealth Highlands Ranch Hospital — Highlands Ranch
Identifiers
NCT: NCT07434817 · 25-2154.cc