Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Improving Identification and Management of Sexual Health Concerns in Women With Cancer: Protocol for a Multilevel, Mixed-Methods Study
ABSTRACT
Background:
Sexual health concerns affect a substantial proportion of women with cancer yet are inconsistently identified and managed in oncology care. Failures occur at multiple levels: screening instruments disagree with one another, patients face barriers to disclosure, providers and systems face barriers to assessment and referral, and clinical guidelines offer recommendations whose implementation determinants are poorly specified. Single-level studies cannot characterize how these failures interact.
Objective:
To characterize identification and management of sexual health concerns in women with cancer across patient, provider, and system levels, and to develop consensus-based, implementable recommendations for improvement.
Methods:
This multilevel, mixed-methods study comprises three aims. Aim 1 characterizes patient experiences and predictors of sexual health concerns, guided by the Biopsychosocial Model, through (1) retrospective analysis of a cohort of 629 patients referred for psycho-oncology care, comparing validated screeners (PROMIS Sexual Function and Satisfaction SF-4; FACT-G GS7) with the NCCN single-item screener and with structured EHR data; (2) semistructured interviews with up to 30 women with breast, gynecologic, or gastrointestinal cancer; and (3) structured chart review of the interviewed patients (n=30), enabling within-patient triangulation of clinical documentation with screener and interview data; and Aim 2 characterizes provider- and system-level barriers and facilitators using the Consolidated Framework for Implementation Research through semistructured interviews with 20 oncology providers and passive observation across four oncology clinic types. Aim 3 compares NCCN and ASCO guideline recommendations, maps discrepancies and implementation gaps, and conducts a 2-round modified Delphi with patient and provider panels (80% consensus threshold) to produce prioritized recommendations, integrated with Aims 1–2 findings via joint display and mapped to implementation strategies using the ERIC taxonomy and the BETTER model.
Results:
The study was approved by the Washington University Institutional Review Board (#202405019; observation protocol #202508134) and is supported by a departmental grant. As of September 2026, 16 of 30 patient interviews and 13 of 20 provider interviews are complete; part of the retrospective cohort analysis is complete and under peer review; 4 clinic observations have been conducted, with an IRB amendment pending for additional sites. Data collection is expected to conclude in December 2026.
Conclusions:
This protocol specifies a multilevel approach linking measurement discordance, patient experience, provider and system determinants, and guideline implementation in a single integrated design. Findings will support implementable, consensus-based strategies for identifying and managing sexual health concerns in oncology.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.