Improving Decision-Making for Low Health Literate Prostate CA Patients

Northwell Health

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Healium

Study type: Interventional

Funder types: Other

Identifiers

NCT05800483

15-192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 327 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a diagnosis of localized prostate cancer and eligible for all treatment options (ie., surgery, radiation, active surveillance);
• had not yet made a treatment decision or begun treatment; and
• have basic proficiency (grade school level) in reading English.

Exclusion criteria

• none

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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327 participants in 2 patient groups

Healium

Experimental group

Description:

Healium is a web-based platform that employs a user-centric design and aims to appeal to a low health literate population. It features a simple language and layout, a large font size, contrasting text and background colors, bright color palette, and use of short labels and headings to describe content.

Treatment:

Behavioral: Healium

Comparison (Healing Choices)

No Intervention group

Description:

The Healing Choices program represents a virtual health center that patients visit to obtain disease and treatment-related information. The software was designed to be open to exploration with an intuitive layout, without restrictions in terms of order of access. Information is stored in virtual rooms, such as a library, a conference room showing videos by survivors who discuss their approach to treatment, and physician offices containing videos of physicians representing different treatment specialties. All information was extensively vetted by health education experts of the National Cancer Institute's Cancer Information Services (CIS).