Patient-focused intervention versus enhanced care-as-usual in facilitating gynecologic cancer patients’ clinical communication about sexual health: protocol for a randomized controlled trial

Résumé fourni par la source

Sexual problems are common, distressing, and persistent for patients with gynecologic cancer (GC). Yet patients with GC often hesitate to raise sexual concerns with their clinicians due to discomfort and inadequate preparation for the discussion. The objective was to evaluate the Starting the Conversation – Gynecologic Cancer (STC-GC) intervention, a patient-focused theory-guided intervention, in patients treated for GC reporting sexual concerns. STC-GC is grounded in social cognitive theory and includes education and training in skills for effective clinical communication about sexual health. This randomized controlled trial will evaluate the efficacy of STC-GC for facilitating patient clinical communication (raise topic, ask question, express concern) about sexual health (primary) and improving patients’ sexual and psychological health outcomes (secondary; sexual activity, sexual function, psychological distress). An additional aim is to examine whether (a) intervention-related increases in self-efficacy and outcome expectancies for sexual health communication mediate effects of STC-GC on patients’ sexual health communication and (b) enhanced sexual health communication mediates effects of STC-GC on patients’ sexual and psychological health outcomes. Two-hundred adult females treated for gynecologic cancer reporting sexual concerns are recruited from an academic cancer center in the U.S. and are randomized to either STC-GC (video, workbook, resource guide) or to Enhanced Care-as-Usual (usual care plus resource guide alone). Clinic dialogue from patients’ next clinic encounter following receipt of either intervention (i.e., at post-intervention) is audio recorded, transcribed, and coded for sexual health communication. Self-report outcome measures are administered to participants at baseline (T1), post-intervention (T2), 2-months post-intervention (T3), and 6-months post-intervention (T4). Primary outcome analyses will use generalized linear mixed-effects models, as appropriate. Secondary outcome analyses will use hierarchical mixed effects models. Mediation models will use structural equation modeling. All analyses account for clustering within-clinicians. As the first efficacy trial of a sexual health communication intervention for patients with GC, findings from this study will contribute to efforts to integrate sexual health into routine cancer care. If STC-GC is effective, next steps include determining optimal dissemination methods. Potential implications for clinical care delivery, research, and the health of GC patients are discussed. This study trial is registered at clinicaltrials.gov (Trial #NCT06904339); registration date: March 31, 2025.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.