Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study

Temple University Health System (TUHS)

Status: Completed

Conditions: Breast Cancer Female

Treatments: Behavioral: Sexual and Menopausal Health Resources; Behavioral: Starting the Conversation Video

Study type: Interventional

Funder types: Other

Identifiers

NCT03624972

14-833-02

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Receiving any treatment for breast cancer or have completed acute treatment for breast cancer < 10 years ago
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

1. Unable to speak English
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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 3 patient groups

Resources Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sexual and Menopausal Health Resources

Resources + Video

Experimental group

Description:

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.

Treatment:

Behavioral: Starting the Conversation Video

Behavioral: Sexual and Menopausal Health Resources

Clinician Arm

No Intervention group

Description:

Clinicians were consented in order to have their clinic visits audio recorded. No outcomes data were collected from clinician participants.