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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016504
• Other study ID #: 21-002955
• Secondary ID: NCI-2022-0981221
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: December 31, 2035

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2034
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Behavioral:
• Health Education
Participate in an adaptive virtual consultation
• Health Education
Participate in a non-adaptive virtual consultation

Other:
• Informational Intervention
Given information-only
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials