VALIDATE: Virtual Agent Linked Intelligent Disease Assessment Tool Engine

NCT03153618 | Withdrawn

• 1 other identifier: 39175
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The collection and analysis of family, medical, lifestyle, and environmental exposure history (a Comprehensive Health History or "CHH") can identify critical risk factors for many chronic and life-threatening conditions, including cancer. Despite its importance, CHH is infrequently documented and analyzed in primary-care medical practice due to numerous hurdles, and currently available tools have proven inadequate to address this critical problem. This study will evaluate the Virtual Agent Linked Intelligent Disease Assessment Tool Engine ("VALIDATE") system as an easy to administer, accurate, cost-effective, and clinically useful tool for collecting and analyzing structured CHH data.

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• Percentage of participants satisfied with usage of VALIDATE

  At the end of the session, participants will be asked if 1. they enjoyed the process d 2. if they prefer this process versus completing a web or paper form and 3. would they recommend the process to others?

  Up to sixteen weeks

• Concordance of data collection - identified relatives

  Accuracy rates will be calculated by dividing the number of VALIDATE identified relatives by the number identified by a trained Clinician

  Up to sixteen weeks

• Concordance of data collection - identified cancers

  Accuracy rates will be calculated by dividing the number of VALIDATE identified cancers by the number identified by a trained Clinician

  Up to sixteen weeks

• Number of VALIDATE subjects versus Control subjects identified for further cancer predisposition assessment.

  Up to sixteen weeks

Study Arms (2)

VALIDATE subjects

EXPERIMENTAL

Will be invited to interact with VALIDATE to determine if they meet referral indications for cancer predisposition assessment.

Other: VALIDATE system

Control

NO INTERVENTION

Current standard of care will be followed

Interventions

VALIDATE system OTHER

Will be invited to interact with VALIDATE to answer questions about Family Cancer history and some personal medical and lifestyle history. Based on responses, VALIDATE will determine if they meet referral indications for cancer predisposition assessment.

VALIDATE subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults above the age of 18

You may not qualify if:

• Children under the age of 18

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Baldeep Singh, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In a two section clinic, the plan is to invite one section of newly enrolled patients coming to clinic for first visit to participate in interacting with VALIDATE while maintaining the standard of care within the other section for similarly matched patients. Parallel allocation design.

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 15, 2017
• Study Start: September 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share