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

Primary Purpose

Prostate Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Education
Health Education
Informational Intervention
Survey Administration
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Arm 1 (AVCT)

Arm 2 (non-AVCT)

Arm 3 (information-only)

Arm Description

Patients participate in an adaptive virtual consultation on trial.

Patients participate in a non-adaptive virtual consultation on trial.

Patients receive information-only on trial.

Outcomes

Primary Outcome Measures

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.
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.
Health outcomes for cancer recurrence using PSA
Measured by Prostate specific antigen ( PSA )
Health outcomes for urinary function using IPSS
Measured using International Prostate symptom score (IPSS)
Health outcomes for sexual function using SHIM score
Measured using Sexual Health inventory for men (SHIM) score
Health outcomes for cancer recurrence using PSA
Measured by Prostate specific antigen ( PSA )
Health outcomes for urinary function
Measured using International Prostate symptom score (IPSS)
Health outcomes for sexual function
Measured using Sexual Health inventory for men (SHIM) score
Health outcomes for cancer recurrence using PSA
Measured by Prostate specific antigen ( PSA )
Health outcomes for urinary function
Measured using International Prostate symptom score (IPSS)
Health outcomes for sexual function
Measured using Sexual Health inventory for men (SHIM) score

Secondary Outcome Measures

Full Information

First Posted
August 1, 2023
Last Updated
August 28, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT06016504
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (AVCT)
Arm Type
Experimental
Arm Description
Patients participate in an adaptive virtual consultation on trial.
Arm Title
Arm 2 (non-AVCT)
Arm Type
Active Comparator
Arm Description
Patients participate in a non-adaptive virtual consultation on trial.
Arm Title
Arm 3 (information-only)
Arm Type
Active Comparator
Arm Description
Patients receive information-only on trial.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Participate in an adaptive virtual consultation
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Participate in a non-adaptive virtual consultation
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Given information-only
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Patient satisfaction measured by post utilization surveys
Description
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.
Time Frame
3-month post treatment decision
Title
Patient satisfaction measured by post utilization surveys
Description
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.
Time Frame
12-month post treatment decision
Title
Health outcomes for cancer recurrence using PSA
Description
Measured by Prostate specific antigen ( PSA )
Time Frame
Baseline
Title
Health outcomes for urinary function using IPSS
Description
Measured using International Prostate symptom score (IPSS)
Time Frame
Baseline
Title
Health outcomes for sexual function using SHIM score
Description
Measured using Sexual Health inventory for men (SHIM) score
Time Frame
Baseline
Title
Health outcomes for cancer recurrence using PSA
Description
Measured by Prostate specific antigen ( PSA )
Time Frame
3-month post treatment decision
Title
Health outcomes for urinary function
Description
Measured using International Prostate symptom score (IPSS)
Time Frame
3-month post treatment decision
Title
Health outcomes for sexual function
Description
Measured using Sexual Health inventory for men (SHIM) score
Time Frame
3-month post treatment decision
Title
Health outcomes for cancer recurrence using PSA
Description
Measured by Prostate specific antigen ( PSA )
Time Frame
12-months post treatment decision
Title
Health outcomes for urinary function
Description
Measured using International Prostate symptom score (IPSS)
Time Frame
12-months post treatment decision
Title
Health outcomes for sexual function
Description
Measured using Sexual Health inventory for men (SHIM) score
Time Frame
12-months post treatment decision

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell R Humphreys
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Mitchell R. Humphreys, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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