NCT06016504

Adaptive Virtual Consultation Tool to Enhance Education and Understanding in Patients with Prostate Cancer

Development and Evaluation of an Adaptive Virtual Consultation Tool for Prostate Cancer Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT) for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in combination with learning preferences and individual disease characteristics to provide focused and guided knowledge on PC tailored to the individual patient. Using an AVCT to enhance patient education may improve patient understanding and result in higher patient satisfaction with treatment decisions amongst men with PC.

Detailed description

PRIMARY OBJECTIVES: I. To develop an adaptive virtual consultation tool for PC (AVCT): Ia. To incorporate and integrate the inputs from a diverse group of patients (including minorities), patient advocates, nursing, physicians and education experts in the design process for the adaptive consultation tool; Ib. Employ user centered iterative design approach to develop an adaptive learning tool on mobile devices that is tailored to individuals based on symptoms, health literacy, learning style, and disease specific characteristics. II. To assess the feasibility, acceptability and usability of AVCT: IIa. To validate the design approach and customization rules at the completion of the participatory design process using a convenience sample of subjects through assessment of system interaction logs and qualitative feedback from users on cognition, ease-of-use, usability and customization efficacy; IIb. To utilize the feasibility study results in (2a) to refine the interface, information presentation, and adaptive customization approach. III. To determine the efficacy of AVCT using a small-scale comparative study: IIIa. To design and execute a three arm comparative study consisting of adaptive virtual consultation, non-adaptive virtual consultation and standard-practice information-only control intervention and assess the comparative efficacy of the tool on the main outcome variable, satisfaction with health care episode; IIIb. To measure changes in other outcome variables at baseline, post-intervention, 3-month and 12-month duration; IIIc. To analyze the mediating influence of decision self-efficacy and a number of moderating factors including preference for decision-making participation and health literacy on outcome variables. OUTLINE: Patients are randomized to 1 of 3 arms. ARM 1: Patients participate in an adaptive virtual consultation on trial. ARM 2: Patients participate in a non-adaptive virtual consultation on trial. ARM 3: Patients receive information-only on trial. After completion of study intervention, patients are followed up at 3- and 12-months post treatment decision.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Health Education	Participate in an adaptive virtual consultation
BEHAVIORAL	Health Education	Participate in a non-adaptive virtual consultation
OTHER	Informational Intervention	Given information-only
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2022-02-10
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2023-08-29
• Last updated: 2024-10-22

Locations

1 site across 1 country: United States