N/A
N=153
Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study
Breast Cancer Female
Bottom Line
View on ClinicalTrials.gov: NCT03624972 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Self-Reported Self-Efficacy for Communicating About Sexual Health Issues — 8.5; 8.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Starting the Conversation Video (Behavioral); Sexual and Menopausal Health Resources (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Fox Chase Cancer Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Reported Self-Efficacy for Communicating About Sexual Health Issues |
7.8; 8.2 | — |
| PRIMARY Self-Reported Self-Efficacy for Communicating About Sexual Health Issues |
7.8; 8.2 | — |
| PRIMARY Self-Reported Outcome Expectancies for Sexual Health Communication |
7.8; 7.8 | — |
| PRIMARY Self-Reported Outcome Expectancies for Sexual Health Communication |
7.8; 7.8 | — |
| PRIMARY Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit |
12; 25 | — |
| PRIMARY Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit |
14; 20 | — |
| SECONDARY Recruitment Rates (Feasibility) |
144 | — |
| SECONDARY Retention Rates (Feasibility) |
69; 71 | — |
| SECONDARY Retention Rates (Feasibility) |
69; 71 | — |
| SECONDARY Intervention Acceptability |
64; 0 | — |
| SECONDARY Sexual Activity |
32; 50; 37; 21 | — |
| SECONDARY Sexual Function |
42.2; 41.6; 55.8; 58.4; 44.7; 46.3 | — |
| SECONDARY General Self-Efficacy for Communication With Provider |
21.6; 22.2 | — |
| SECONDARY Barriers to Communicating About Sexual Health |
29.0; 27.8 | — |
| SECONDARY Self-Reported Anxiety |
7.3; 6.6 | — |
| SECONDARY Self-Reported Depression |
4.4; 4.6 | — |
| SECONDARY Self-Reported Quality of Life |
62.6; 61.8 | — |
| SECONDARY Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects |
9.1; 9.3 | — |
| SECONDARY Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects |
9.1; 9.3 | — |
| SECONDARY Self-Reported Self-Efficacy for Communicating About About Menopausal Health |
9.0; 9.3 | — |
| SECONDARY Self-Reported Self-Efficacy for Communicating About About Menopausal Health |
9.0; 9.3 | — |
| SECONDARY Self-Reported Outcome Expectancies for Communication About Treatment Side Effects |
8.6; 8.8 | — |
| SECONDARY Self-Reported Outcome Expectancies for Communication About Treatment Side Effects |
8.6; 8.8 | — |
| SECONDARY Self-Reported Outcome Expectancies for Communication About Menopausal Health |
8.3; 8.7 | — |
| SECONDARY Self-Reported Outcome Expectancies for Communication About Menopausal Health |
8.3; 8.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Receiving any treatment for breast cancer or have completed acute treatment for breast cancer 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.
Data sourced from ClinicalTrials.gov (NCT03624972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.