Breast Cancer Female, Sexual Dysfunction
Conditions
Keywords
Breast cancer, sexual health, educational video
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.
Interventions
OTHEREducational video series
The intervention is a web-based educational video series that was developed using a patient-centered approach that discusses breast cancer treatment, sexual health side effects, and provides treatment and mitigation strategies for these side effects.
Sponsors
University of Colorado, Denver
International Society for the Study of Women's Sexual Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah E Tevis, MD
University of Colorado, Denver
Outcome results
None listed