Randomized trial to test sexual-health communication support in gynecologic cancer care

A published protocol for a randomized controlled trial will test whether a patient-focused program helps women treated for gynecologic cancer discuss sexual health with their clinicians. The planned study, conducted at an academic cancer center in the United States, compares the Starting the Conversation–Gynecologic Cancer intervention, abbreviated STC-GC, with enhanced usual care. Its primary outcome is whether patients communicate about sexual health during a clinical encounter by raising the topic, asking a question or expressing a concern. The document describes the study’s methods and planned analyses; it contains no efficacy results and therefore does not establish that the intervention improves communication, sexual health or psychological well-being.

Researchers plan to enroll 200 adult females treated for gynecologic cancer who report sexual concerns. Eligible participants will be assigned to receive either STC-GC or Enhanced Care-as-Usual, abbreviated ECAU. The STC-GC group will receive a video, workbook and resource guide, while the ECAU group will receive the resource guide alone. The intervention is grounded in social cognitive theory and combines education with training in skills for effective clinical communication about sexual health. This design isolates the added components of the multicomponent program from the information available to all participants. The trial is registered at ClinicalTrials.gov as NCT06904339, with a registration date of March 31, 2025.

The central communication outcome will be assessed from the dialogue recorded during each participant’s next clinic encounter after receipt of the assigned materials. Researchers plan to audio-record, transcribe and code these encounters for evidence that patients raised the sexual-health topic, asked a question or expressed a concern. This direct observation of a clinical encounter will be complemented by self-report assessments collected at baseline, immediately after the intervention, two months afterward and six months afterward. Secondary outcomes include sexual activity, sexual function and psychological distress. The investigators will also examine whether intervention-related increases in self-efficacy and outcome expectancies for sexual-health communication mediate the intervention’s effects on communication. A second mediation analysis will test whether enhanced sexual-health communication mediates effects on sexual and psychological outcomes. These are proposed causal pathways to be evaluated in the trial, not relationships already demonstrated by the protocol.

Primary outcome analyses will use generalized linear mixed-effects models, as appropriate, while secondary outcome analyses will use hierarchical mixed-effects models. Mediation models will use structural equation modeling, and the analyses are designed to account for clustering within clinicians. The protocol describes STC-GC as the first efficacy trial of a sexual-health communication intervention for patients with gynecologic cancer. Its stated rationale is that sexual problems are common, distressing and persistent among people with gynecologic cancer, while patients may hesitate to raise sexual concerns because of discomfort or inadequate preparation for discussion. If the intervention proves effective, the authors state that a subsequent step would be to determine optimal dissemination methods, but the present study is limited to a single U.S. academic cancer center and has not yet generated findings about the intervention’s effects. Accordingly, the protocol evaluates a communication-support strategy within cancer care rather than a treatment for cancer itself, and the possible benefits of the program remain to be determined through recruitment, follow-up and analysis.

Subject of Research: Evaluation of a patient-focused intervention for sexual-health communication in gynecologic cancer care

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

Article References: Reese, J. B., Gorman, J. R., El-Jawahri, A., Mantia-Smaldone, G., Sorice, K. A., Zhang, L., Romeiro, F. B., McIlhenny, S., Mir-Young, A., & Bober, S. L. (2026). Patient-focused intervention versus enhanced care-as-usual in facilitating gynecologic cancer patients’ clinical communication about sexual health: protocol for a randomized controlled trial. BMC Cancer. https://doi.org/10.1186/s12885-026-16907-1

Image Credits: AI Generated

DOI: 10.1186/s12885-026-16907-1

Keywords: gynecologic cancer, sexual health, clinical communication, randomized trial, patient-centered care, communication skills, self-efficacy, psychological distress, cancer survivorship, Patient-focused, intervention, versus