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

October 18, 2024 updated by: Mitchell Humphreys, Mayo Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The participants in this study will be community dwelling, males with prostate cancer (PC) and their healthcare advocate, if applicable
  • Proficiency in English is required

Exclusion Criteria:

  • Mental incompetency to participate in the study and/or no treatment option due to other health reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (AVCT)
Patients participate in an adaptive virtual consultation on trial.
Other: Survey Administration
Ancillary studies
Behavioral: Health Education
Participate in an adaptive virtual consultation
Behavioral: Health Education
Participate in a non-adaptive virtual consultation
Active Comparator: Arm 2 (non-AVCT)
Patients participate in a non-adaptive virtual consultation on trial.
Other: Survey Administration
Ancillary studies
Behavioral: Health Education
Participate in an adaptive virtual consultation
Behavioral: Health Education
Participate in a non-adaptive virtual consultation
Active Comparator: Arm 3 (information-only)
Patients receive information-only on trial.
Other: Survey Administration
Ancillary studies
Other: Informational Intervention
Given information-only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction measured by post utilization surveys
Time Frame: 3-month post treatment decision

Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools.

Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
3-month post treatment decision
Patient satisfaction measured by post utilization surveys
Time Frame: 12-month post treatment decision

Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools.

Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
12-month post treatment decision
Health outcomes for cancer recurrence using PSA
Time Frame: Baseline
Measured by Prostate specific antigen ( PSA )
Baseline
Health outcomes for urinary function using IPSS
Time Frame: Baseline
Measured using International Prostate symptom score (IPSS)
Baseline
Health outcomes for sexual function using SHIM score
Time Frame: Baseline
Measured using Sexual Health inventory for men (SHIM) score
Baseline
Health outcomes for cancer recurrence using PSA
Time Frame: 3-month post treatment decision
Measured by Prostate specific antigen ( PSA )
3-month post treatment decision
Health outcomes for urinary function
Time Frame: 3-month post treatment decision
Measured using International Prostate symptom score (IPSS)
3-month post treatment decision
Health outcomes for sexual function
Time Frame: 3-month post treatment decision
Measured using Sexual Health inventory for men (SHIM) score
3-month post treatment decision
Health outcomes for cancer recurrence using PSA
Time Frame: 12-months post treatment decision
Measured by Prostate specific antigen ( PSA )
12-months post treatment decision
Health outcomes for urinary function
Time Frame: 12-months post treatment decision
Measured using International Prostate symptom score (IPSS)
12-months post treatment decision
Health outcomes for sexual function
Time Frame: 12-months post treatment decision
Measured using Sexual Health inventory for men (SHIM) score
12-months post treatment decision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Mitchell R. Humphreys, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Actual)

July 9, 2024

Study Completion (Actual)

July 9, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-002955 (Other Identifier: Mayo Clinic in Arizona)
  • NCI-2022-09812 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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