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

NCT06016504 | Terminated

• 2 other identifiers: 21-002955NCI-2022-09812
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (3)

Arm 1 (AVCT)

EXPERIMENTAL

Patients participate in an adaptive virtual consultation on trial.

Behavioral: Health Education; Other: Survey Administration

Arm 2 (non-AVCT)

ACTIVE COMPARATOR

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

Behavioral: Health Education; Other: Survey Administration

Arm 3 (information-only)

ACTIVE COMPARATOR

Patients receive information-only on trial.

Other: Informational Intervention; Other: Survey Administration

Interventions

Health Education BEHAVIORAL

Participate in an adaptive virtual consultation

Arm 1 (AVCT)

Informational Intervention OTHER

Given information-only

Arm 3 (information-only)

Survey Administration OTHER

Ancillary studies

Arm 1 (AVCT); Arm 2 (non-AVCT); Arm 3 (information-only)

Eligibility Criteria

• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mental incompetency to participate in the study and/or no treatment option due to other health reasons

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mitchell R. Humphreys, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 29, 2023
• Study Start: February 10, 2022
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

US (1)