Promoting Effective Clinical Communication about Sexual Health after Gynecologic Cancer: A Randomized Controlled Trial of a Patient-Focused Intervention

Sexual problems are common, distressing and persistent for patients with gynecologic cancer (GC). Yet most patients with GC who experience sexual concerns do not raise them with their clinicians, often due to a lack of preparation for how to do so effectively. Negative beliefs, such as low self-efficacy for initiating discussions of sexual health or expectations for the discussion, further limit patients’ active engagement in these discussions. A patient-focused theory-guided intervention, Starting the Conversation (STC), could be ideally suited to address these challenges and empower patients to drive clinical discussions to meet their needs. STC was developed for use with breast cancer (BC) patients and found effective in that population. Compared to BC patients, however, GC patients undergo different treatments, experience unique sexual health concerns, and have distinct needs for a sexual health communication intervention. Therefore, we modified STC to suit the needs of women with GC and conducted a pilot trial of the new intervention, called STC – Gynecologic Cancer (STC-GC), finding strong support for its feasibility and acceptability. Before this intervention can be disseminated, its efficacy in the target population must be evaluated. The primary objective of the proposed study is thus to evaluate the efficacy of the STC-GC intervention among patients treated for GC reporting sexual concerns. Female patients with any stage GC (N=200) will be randomized to receive either the STC-GC intervention [video, workbook, and resource guide] or to a control [usual care plus resource guide]. In Aim 1, we will evaluate the efficacy of STC-GC in facilitating patient clinical communication about sexual health (primary), assessed using rigorous dialogue analysis of patients’ clinical communication about sexual health, and in improving patients’ sexual and psychological health outcomes at post-intervention and 2- and 6-month follow-up (secondary). In Aim 2, we will examine whether intervention-related increases in patients’ self-efficacy and outcome expectancies for sexual health communication mediate effects of STC-GC on patients’ communication (Aim 2a) and whether enhanced sexual health communication mediates effects of STC-GC on patients’ sexual and psychological health outcomes (Aim 2b). In Aim 3, we will conduct in-depth qualitative interviews with a purposive sample of patients in STC-GC and with clinicians of GC patients to provide information from multiple perspectives to contextualize and interpret the quantitative findings of the trial. As the first efficacy trial of a sexual health communication intervention for women with GC, findings from this study will be instrumental in advancing efforts to integrate sexual health into routine cancer care. Further, the proposed study has a number of unique features, including a qualitative investigation of multiple perspectives, novel application of dialogue analysis, analysis of multiple intervention mediators, and a medically inclusive patient population, which heighten study impact and innovation. Data from this study will serve as the platform for a future dissemination trial of STC-GC in multiple settings.