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Randomized Controlled Trial
. 2023 Oct 20:25:e46552.
doi: 10.2196/46552.

Preference Elicitation and Treatment Decision-Making Among Men Diagnosed With Prostate Cancer: Randomized Controlled Trial Results of Healium

Michael A Diefenbach  1 , Allison Marziliano  1 , Erin K Tagai  2 , Halie Pfister  1 , Emmanuel Lapitan  2 , Simon J Hall  1   3 , Manish Vira  1   3 , Said Ibrahim  1 , Kelli Aibel  1 , Alexander Kutikov  4 , Eric M Horwitz  5   6 , Curtis Miyamoto  5   6 , Adam C Reese  4   6 , Suzanne M Miller  2
Affiliations
Randomized Controlled Trial

Preference Elicitation and Treatment Decision-Making Among Men Diagnosed With Prostate Cancer: Randomized Controlled Trial Results of Healium

Michael A Diefenbach et al. J Med Internet Res. .

Abstract

Background: Elicitation of patients' preferences is an integral part of shared decision-making, the recommended approach for prostate cancer decision-making. Existing decision aids for this population often do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patients' treatment preferences and is designed for a low health literate population.

Objective: This study used a randomized controlled trial to evaluate whether Healium, designed to target preference elicitation, is as efficacious as Healing Choices, a comprehensive education and decision tool, in improving outcomes for decision-making and emotional quality of life.

Methods: Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, a decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6 weeks, and 3 months post baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, and preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.

Results: A total of 327 individuals consented to participate in the study (171 were randomized to the Healium intervention arm and 156 were randomized to Healing Choices). The majority of the sample was non-Hispanic (272/282, 96%), White (239/314, 76%), married (251/320, 78.4%), and was on average 62.4 (SD 6.9) years old. Within both arms, there was a significant decrease in decisional conflict from baseline to 6 weeks postbaseline (Healium, P≤.001; Healing Choices, P≤.001), and a significant increase in satisfaction with one's decision from 6 weeks to 3 months (Healium, P=.04; Healing Choices, P=.01). Within both arms, anxiety/tension (Healium, P=.23; Healing Choices, P=.27) and depression (Healium, P=.001; Healing Choices, P≤.001) decreased from baseline to 6 weeks, but only in the case of depression was the decrease statistically significant.

Conclusions: Healium, our brief decision aid focusing on treatment preference elicitation, is as successful in reducing decisional conflict as our previously tested comprehensive decision aid, Healing Choices, and has the added benefit of brevity, making it the ideal tool for integration into the physician consultation and electronic medical record.

Trial registration: ClinicalTrials.gov NCT05800483; https://clinicaltrials.gov/study/NCT05800483.

Keywords: RCT; decision support; decision tool; decision-making; emotional; men’s health; oncology; patient preferences; preference; preference elicitation software; prostate; prostate cancer; randomized controlled trial; web-based intervention.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Change in decisional conflict by arm over time. DCS: Decisional Conflict Scale.
See this image and copyright information in PMC

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