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Completed

NCT Number: NCT06121258

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

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Genital Diseases Neoplasms Neoplasms by Site Sexual Dysfunction Sexual Dysfunction, Physiological Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Health

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Educational video series

Other

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.

Primary outcomes

  1. Acceptability of the educational video series after six-months of access and use by breast cancer patients as measured by AIM instrument.

    Time frame: 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).

  2. Appropriateness of the educational video series after six-months of access and use by breast cancer patients as measured by IAM instrument.

    Time frame: 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).

  3. 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.

    Time frame: 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 outcomes

  1. Change from baseline in sexual health and function at six-months, as measured by the PROMIS Sexual Function v2 Brief Profile (Female)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • International Society for the Study of Women's Sexual Health

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2023
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.

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