Breast Cancer Females, Newly Diagnosed Breast Cancer
Conditions
Keywords
English and Spanish Speaking
Brief 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. 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
BEHAVIORALSexual 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.
OTHERStandard Care (in control arm)
Standard Care
Sponsors
University of Colorado, Denver
Cancer League of Colorado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant self-efficacy discussing sexual health with breast cancer providers | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of medical and supportive services outside of treatment-plan related visits | 12 months | 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. |
| Qualitative measure: Patient-reported experiences with sexual health and perceived impact of the video content. | One time, 60 minute interview, 6-12 months after enrollment | 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. |
Countries
United States
Contacts
CONTACTSarah Leslie, MPH
CONTACTSarah Tevis, MD
PRINCIPAL_INVESTIGATORSarah Tevis
University of Colorado, Denver
Outcome results
None listed