Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016504
Status:
TERMINATED
Last Update Posted:
2024-02-12
First Post:
2023-08-01
Brief Title:
Adaptive Virtual Consultation Tool to Enhance Education and Understanding in Patients with Prostate Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Development and Evaluation of an Adaptive Virtual Consultation Tool for Prostate Cancer Patients
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lowslow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-09812 | REGISTRY | None | None |
| 21-002955 | OTHER | Mayo Clinic in Arizona | None |