Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Age less than 18 years old
Stage 0 or Stage IV breast cancer
Prior breast cancer diagnosis
Non-breast cancer diagnoses
Trial design
Treatments tested in this trial
- Sexual Health Educational Video Series
- Standard Care (in control arm)
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
4University of Colorado Hospital80045, AuroraColorado, United States
Denver Health Hospital and Clinic80204, DenverColorado, United States
UCHealth Cherry Creek Medical Center80206, DenverColorado, United States
UCHealth Highlands Ranch Hospital80129, Highlands RanchColorado, United States
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
Cancer League of Colorado
Collaborator
Source ClinicalTrials.gov