Enhancing Clinical Communication About Sexual Health for Women With Gynecologic Cancer: Adaptation of a Multimedia Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gynecologic Cancer
- Sponsor
- Fox Chase Cancer Center
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Feasibility - Enrollment
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The central goal of this randomized, controlled pilot study is to examine the feasibility, acceptability, and preliminary effects of an educational intervention (called "Starting the Conversation"; STC) on patient communication about sexual health in gynecologic cancer and other patient health outcomes. Approximately 30 women with a diagnosis of gynecologic cancer will be randomized to either participate in either the Starting the Conversation (STC) condition, consisting of an educational video, workbook, and list of resources on sexual and menopausal health, or to a control condition offering the resource guide only. Patients will be asked to review intervention materials prior to their next clinic visit with their gynecologic 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of any stage (I-IV) gynecologic cancer (uterine, ovarian, cervical, vaginal/vulvar, fallopian tube, peritoneal)
- •Receiving any treatment for gynecologic cancer or have completed acute treatment \< 10 years ago
- •Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
Exclusion Criteria
- •Not able to speak English
- •Eastern Cooperative Oncology Group (ECOG) Performance status score \> 2
- •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
Feasibility - Enrollment
Time Frame: Baseline
Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation
Feasibility - Retention
Time Frame: 2 months
Number of enrolled participants that complete the final study survey.
Feasibility - Intervention Completion
Time Frame: 2 weeks
Number of participants randomized to receive the Starting the Conversation intervention who report having engaged at least somewhat with the video and/or accompanying workbook.
Acceptability
Time Frame: 2 weeks
The number of participants randomized to receive the Starting the Conversation intervention who endorse at least 6 of 8 core components of the Starting the Conversation Intervention (defined as satisfaction with the intervention, informativeness of the intervention, helpfulness of the intervention, relevance of the intervention, ease of participation, approval of the intervention format, likelihood of recommending the intervention to others, and perceived importance of the intervention for people with gynecologic cancer).
Secondary Outcomes
- Self-Efficacy - Post-Intervention(2 weeks)
- Self-Efficacy - 2-Month Follow Up(2 months)
- Clinical Communication - Discussion of Sexual Health(2 weeks)
- Clinical Communication - Raising Topic of Sexual Health(2 weeks)
- Clinical Communication - Asking a Question About Sexual Health(2 weeks)
- Change in Sexual Function(baseline to 2 months)
- Sexual Activity(2 months)
- Psychological Distress - Depression(2 months)
- Psychological Distress - Anxiety(2 months)