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Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study

NCT03624972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2021-03-16

Study results available
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Summary

The goal of this study is to evaluate an educational video intervention (called Starting the Conversation) aimed to enhance breast cancer patients' beliefs about and communication with respect to sexual concerns. In the current study, 128 breast cancer outpatients will be randomized to either participate in the video intervention and to receive a resource guide addressing sexual and menopausal health or to receive the resource guide alone. Patients will be asked to participate in the video and/or read through the resource guide prior to their clinic visit with their breast cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being and health-related QOL.

Conditions

  • Breast Cancer Female

Interventions

BEHAVIORAL

Starting the Conversation Video

The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.

BEHAVIORAL

Sexual and Menopausal Health Resources

Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal \& sexual health clinic.

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • Fox Chase Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-27
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624972 on ClinicalTrials.gov