NCT05800483

Improving Decision-Making for Low Health Literate Prostate CA Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Background: Elicitation of patients' preferences is an integral part of shared decision making, the recommended approach for prostate cancer decision making. However, existing decision aids for this population do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patient's treatment preferences and is designed for a low health literate population. 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. Method: 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, an extensive 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, preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Healium	web-based platform to elicit patients' preferences about prostate cancer treatment and designed for low health literature populations

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2023-04-05
• Last updated: 2023-04-05

Locations

2 sites across 1 country: United States