Clinical trial NCT06016504: Adaptive Virtual Consultation Tool to Enhance Education and Understanding in Patients with Prostate Cancer
Official title: Development and Evaluation of an Adaptive Virtual Consultation Tool for Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 18
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction measured by post utilization surveys
timeFrame: 3-month post treatment decision
measure: Patient satisfaction measured by post utilization surveys
timeFrame: 12-month post treatment decision
measure: Health outcomes for cancer recurrence using PSA
timeFrame: Baseline
measure: Health outcomes for urinary function using IPSS
timeFrame: Baseline
measure: Health outcomes for sexual function using SHIM score
timeFrame: Baseline
measure: Health outcomes for cancer recurrence using PSA
timeFrame: 3-month post treatment decision
measure: Health outcomes for urinary function
timeFrame: 3-month post treatment decision
measure: Health outcomes for sexual function
timeFrame: 3-month post treatment decision
measure: Health outcomes for cancer recurrence using PSA
timeFrame: 12-months post treatment decision
measure: Health outcomes for urinary function
timeFrame: 12-months post treatment decision
measure: Health outcomes for sexual function
timeFrame: 12-months post treatment decision
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mitchell R. Humphreys, M.D.
role: PRINCIPAL_INVESTIGATOR
References: