Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study
NCT ID: NCT03624972
Last Updated: 2021-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
153 participants
INTERVENTIONAL
2018-05-27
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Resources Only
Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.
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.
Resources + Video
Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.
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.
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.
Clinician Arm
Clinicians were consented in order to have their clinic visits audio recorded. No outcomes data were collected from clinician participants.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
3. Willing to have clinic visit audio recorded
Exclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance score \> 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member
3. Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.
21 Years
FEMALE
No
Sponsors
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American Cancer Society, Inc.
OTHER
Fox Chase Cancer Center
OTHER
Responsible Party
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Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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14-833-02
Identifier Type: -
Identifier Source: org_study_id
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