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

December 14, 2023 updated by: University of Colorado, Denver
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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.
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).
6 months
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).
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.
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).
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)
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.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Sarah E Tevis, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-1734.cc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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