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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sexual Health Educational Video Series
BehavioralParticipants 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 interventionStandard Care
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 2 months, 4 months, 6 months2
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.
Time frame
Baseline, 2 months, 4 months, 6 monthsSecondary outcomes
1
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.
Time frame
12 months2
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.
Time frame
One time, 60 minute interview, 6-12 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Cancer League of Colorado
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: