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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Behavioral: Health Education
* Behavioral: Health Education
* Other: Informational Intervention
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participants in this study will be community dwelling, males with 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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |