JMIR Publications

ABSTRACT

Background:

Surgery is the most common treatment for localized small kidney masses (SKM, up to 4 cm), despite lacking evidence of improved overall survival. Non-surgical management options have gained increasing recognition over the past decade, as evidence supports the indolence of most SKMs. Decision aids (DAs) have been shown to improve patient comprehension of the benefits and risks of treatment options, overall decision quality, and may improve consideration of all major options according to individual health priorities and preferences.

Objective:

The primary aim of this pilot randomized controlled trial (RCT) is to evaluate the impact of a new web-based DA on treatment decisions for patients with SKM, i.e. selection of surgical vs. non-surgical treatment options. Secondary objectives include an assessment of decision-making outcomes: decisional conflict, decision satisfaction, and an understanding of individual preferences for treatment that incorporate the tradeoffs associated with surgical vs. non-surgical interventions.

Methods:

Three phases comprise the construction and evaluation of a new web-based DA on treatment of SKM. In phase 1 this DA was developed iteratively in print format through a multidisciplinary design committee incorporating patient focus groups and feedback. Phase 2 was an observational study on patient knowledge and decision-making measures after randomization to receive the printed DA or institutional educational materials, which identified further educational needs applied to a web-based DA. Phase 3 will preliminarily evaluate the web-based DA: in a pilot RCT, 50 adults diagnosed with SKMs will receive the web-based DA or an existing web-based institutional website at urology clinics in a large academic medical center. The web-based DA applies risk communication and information about the diagnosis and treatment options, elicits preferences regarding treatment options, and provides a set of options to consider with their doctor based on a decision-analytic model of benefits/harm analysis that accounts for comorbidity, age group, and tumor features. Self-assessment questionnaires and treatment decision data will be gathered before and after viewing the educational material.

Results:

The current phase will consist of a pilot RCT to establish feasibility and preliminary evaluation of decision outcomes. The previous phases of this study supported feasibility of providing the printed DA in urology clinics just before clinical consultation, and demonstrated increased patient knowledge about the diagnosis and treatment options, as well as greater likelihood of favoring non-surgical treatment just before consultation. This study was funded by the National Cancer Institute. Recruitment will begin in August 2022.

Conclusions:

A web-based DA has been designed to address educational needs for patients making treatment decisions for SKM, accounting for kidney disease, other comorbidities, as well as treatment-related benefits and risks. Outcomes from this study will evaluate the potential of a web-based DA in personalizing treatment decisions and in helping patients weigh attributes of surgical vs. non-surgical treatment options for their SKMs. Clinical Trial: ClinicalTrials.gov NCT05387863 Prospectively registered on May 24, 2022.