Advancing knowledge of values-clarification processes during complex decision making among older adults with advanced cancer: protocol for a pilot randomized trial using simulated patient-clinician encounters (Preprint)

BACKGROUND Older adults represent the majority of individuals diagnosed with cancer in the United States and often face complex treatment decisions that require balancing survival benefits with quality-of-life considerations. Despite the emphasis on shared decision-making, many patients report that clinical guidance does not reflect their personal values. Values-clarification tools have shown slight improvements in aligning care with patient values; however, the factors by which these tools influence decision-making are less studied. OBJECTIVE This pilot study aims to estimate the quality of values-clarification and shared decision-making processes that occur during simulated diagnosis encounters for advanced cancer among participants who do and do not receive a values-clarification tool. METHODS Pilot randomized study using simulated patient-clinician encounters to assess how values are elicited, processed, and integrated into treatment decisions. Participants aged 60 and older with an advanced cancer diagnosis will be randomized to receive either a digital values-clarification instrument co-developed through stakeholder engagement, referred to as Values and Outcomes to Improve Cancer Experiences (VOICE), or a general communication guide from the American Cancer Society (ACS). Each participant will engage in two simulated encounters (values-based and non-values-based), conducted by trained medical students portraying oncologists. The simulations are structured using a situational awareness framework. A novel rating scale, referred to as VECTORS, will measure the quality of rapport building, clinician engagement, and patient engagement through observation. Additional validated instruments will be used to quantify observed (OPTION-5) and patient-reported (CollaboRATE) SDM behaviors and patients’ perceived usefulness of either VOICE or the ACS guide (PrepDM). Qualitative interviews will be used to better understand participants’ experiences during encounters and perceptions of VOICE or ACS guide. RESULTS The study was conducted between September 2024 and December 2024, with a total of 44 participants, and is ready for data analysis. CONCLUSIONS This pilot study will provide preliminary evidence into the quality of values-clarification processes occurring during patient-clinician encounters among older adults making treatment decisions for advanced cancer.