Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Female
- Sponsor
- Fox Chase Cancer Center
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Receiving any treatment for breast cancer or have completed acute treatment for breast cancer \< 10 years ago
- •Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
- •Willing to have clinic visit audio recorded
Exclusion Criteria
- •Unable to speak English
- •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
- •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.
Outcomes
Primary Outcomes
Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
Time Frame: 2 months
Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.
Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit
Time Frame: 2 weeks
As coded from clinic visit audio, the number of patients who raise the topic of sexual health during their encounter (out of encounters where a sexual health discussion occurred).
Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit
Time Frame: 2 weeks
As coded from clinic visit audio, the number of patients who ask at least one question about sexual health.
Self-Reported Outcome Expectancies for Sexual Health Communication
Time Frame: 2 months
Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
Secondary Outcomes
- Sexual Function(2 months)
- Self-Reported Anxiety(2 months)
- Self-Reported Depression(2 months)
- Self-Reported Outcome Expectancies for Communication About Menopausal Health(2 months)
- Recruitment Rates (Feasibility)(baseline)
- Intervention Acceptability(2 weeks)
- Barriers to Communicating About Sexual Health(2 months)
- Self-Reported Outcome Expectancies for Communication About Treatment Side Effects(2 months)
- Retention Rates (Feasibility)(2 months)
- General Self-Efficacy for Communication With Provider(2 months)
- Self-Reported Quality of Life(2 months)
- Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects(2 months)
- Sexual Activity(2 months)
- Self-Reported Self-Efficacy for Communicating About About Menopausal Health(2 months)