Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment
- Conditions
- Breast Cancer FemaleSexual Dysfunction
- Interventions
- Other: Educational video series
- Registration Number
- NCT06121258
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
The purpose of this study is to assess the acceptability, appropriateness, and feasibility of a educational video series for patients going through breast cancer treatment.
- Detailed Description
This is a prospective, mixed methods pilot study to evaluate the acceptability, appropriateness, and feasibility of a novel educational video series for patients going through breast cancer treatment. The video series addresses topics such as what to expect from breast surgery, how to prepare for breast surgery, treatment effects of breast cancer therapies, and mitigation and communication strategies for navigating breast cancer treatment.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- Stage I-III invasive breast cancer within one month of initial multi-disciplinary clinic visit or surgical consultation
- Ability to complete survey material independently
- Able to read and speak English
- Willingness to comply with study material and procedures
- Age < 18 years old
- Stage 0 or IV breast cancer
- Non-breast cancer diagnoses
- History of anti-hormonal therapy, chemotherapy, or radiotherapy not related to breast cancer
- Prior breast cancer diagnosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Video website access Educational video series Participants will gain access to the educational video website in order to watch the series.
- Primary Outcome Measures
Name Time Method Acceptability of the educational video series after six-months of access and use by breast cancer patients as measured by AIM instrument. 6 months The Acceptability of Intervention Measure (AIM) is a validated instrument used to measure the acceptability of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater acceptability).
Appropriateness of the educational video series after six-months of access and use by breast cancer patients as measured by IAM instrument. 6 months The Intervention Appropriateness Measure (IAM) is a validated instrument used to measure the appropriateness of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater appropriateness).
Determine the sustainability of the educational video series after six-months of access and use by breast cancer patients as measured by the FIM instrument. 6 months The Feasibility of Intervention Measure (FIM) is a validated instrument used to measure the feasibility, or sustainability, of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater feasibility).
- Secondary Outcome Measures
Name Time Method Change from baseline in sexual health and function at six-months, as measured by the PROMIS Sexual Function v2 Brief Profile (Female) Baseline, 6 months The Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function v2 Brief Profile (Female) is a well-validated tool in oncology patients to assess sexual health. Calibrated subdomain scores are expressed as T-scores (mean=50, standard deviation=10). A T-score 50 corresponds to the mean response among cancer survivors used for previous item testing. Higher scores indicate better outcomes within the domain. We will assess the change at 6 months from baseline.
Trial Locations
- Locations (1)
University of Colorado Health
🇺🇸Aurora, Colorado, United States