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

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: Prostate Carcinoma
• Intervention / Treatment: Other: Survey Administration; Behavioral: Health Education; Behavioral: Health Education; Other: Informational Intervention

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	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	Measured by Prostate specific antigen ( PSA )	Baseline
Health outcomes for urinary function using IPSS	Measured using International Prostate symptom score (IPSS)	Baseline
Health outcomes for sexual function using SHIM score	Measured using Sexual Health inventory for men (SHIM) score	Baseline
Health outcomes for cancer recurrence using PSA	Measured by Prostate specific antigen ( PSA )	3-month post treatment decision
Health outcomes for urinary function	Measured using International Prostate symptom score (IPSS)	3-month post treatment decision
Health outcomes for sexual function	Measured using Sexual Health inventory for men (SHIM) score	3-month post treatment decision
Health outcomes for cancer recurrence using PSA	Measured by Prostate specific antigen ( PSA )	12-months post treatment decision
Health outcomes for urinary function	Measured using International Prostate symptom score (IPSS)	12-months post treatment decision
Health outcomes for sexual function	Measured using Sexual Health inventory for men (SHIM) score	12-months post treatment decision

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

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: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• 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