Adaptive Virtual Consultation Tool to Enhance Education and Understanding in Patients with Prostate Cancer
NCT ID: NCT06016504
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
18 participants
INTERVENTIONAL
2022-02-10
2024-07-09
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm 1 (AVCT)
Patients participate in an adaptive virtual consultation on trial.
Health Education
Participate in an adaptive virtual consultation
Survey Administration
Ancillary studies
Arm 2 (non-AVCT)
Patients participate in a non-adaptive virtual consultation on trial.
Health Education
Participate in a non-adaptive virtual consultation
Survey Administration
Ancillary studies
Arm 3 (information-only)
Patients receive information-only on trial.
Informational Intervention
Given information-only
Survey Administration
Ancillary studies
Interventions
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Health Education
Participate in an adaptive virtual consultation
Health Education
Participate in a non-adaptive virtual consultation
Informational Intervention
Given information-only
Survey Administration
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* Proficiency in English is required
Exclusion Criteria
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mitchell Humphreys
Principal Investigator
Principal Investigators
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Mitchell R. Humphreys, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2022-09812
Identifier Type: REGISTRY
Identifier Source: secondary_id
21-002955
Identifier Type: OTHER
Identifier Source: secondary_id
21-002955
Identifier Type: -
Identifier Source: org_study_id
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