Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment

Conditions
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Breast Cancer Female, Sexual Dysfunction

Intervention / Treatment
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* Other: Educational video series


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video website access<br>Participants will gain access to the educational video website in order to watch the series. | Other: Educational video series<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the educational video series after six-months of access and use by breast cancer patients as measured by AIM instrument. | 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). | 6 months | 
| Appropriateness of the educational video series after six-months of access and use by breast cancer patients as measured by IAM instrument. | 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). | 6 months | 
| 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. | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sexual health and function at six-months, as measured by the PROMIS Sexual Function v2 Brief Profile (Female) | 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. | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, sexual health, educational video