Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07434817

Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Females Newly Diagnosed Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sexual Health Educational Video Series

Behavioral

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.

Standard Care (in control arm)

Other

Standard Care

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Use of medical and supportive services outside of treatment-plan related visits

    Time frame: 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.

  2. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Leslie, MPH

CONTACT

[email protected]

303-724-8995

Sarah Tevis, MD

CONTACT

[email protected]

303-724-2750

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Cancer League of Colorado

Registry information

Official study title

Improving Breast Cancer Patients' Self-Efficacy and Sexual Health Quality of Life

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.