NCT07700199

Brief Summary

This project conducts exploratory work on a HIPAA-compliant, large language model (LLM)-based tool that integrates structured and unstructured oncology electronic health record (EHR) data to automate the development of tailored SCPs, paired with a patient-facing chatbot to answer questions about the SCP. Unlike generic AI documentation tools, this system establishes benchmarks for SCP development and embeds user-centered design (UCD) directly into prompt engineering and model governance workflows.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
12mo left

Started Aug 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility: Recruitment Retention

    Feasibility of the interactive AI-SCP and chatbot. This outcome measure will report the proportion of subjects who were retained from recruitment.

    up to 7 days

Secondary Outcomes (1)

  • Acceptability/Usability: System Usability Scale

    up to 7 days

Other Outcomes (2)

  • Change in PROMIS Anxiety

    up to 7 days

  • Change in Cancer Worry Scale

    up to 7 days

Study Arms (1)

SCP Chatbot

OTHER

Participants will receive an AI-SCP and access to the SCP chatbot from an oncologist for 7 days .

Other: SCP Chatbot

Interventions

A secure LLM pipeline with structured and unstructured EHR data to automatically generate Survivorship Care Plans (SCPs) and develop a patient-facing chatbot to support comprehension. The SCP chatbot will leverage GARDE-Chat, an NCI-funded open-source chatbot platform

Also known as: GARDE-Chat
SCP Chatbot

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult cancer survivors
  • Age +18 years,
  • Speak and understand English
  • Affiliated with the Huntsman Cancer Institute.

You may not qualify if:

  • Under age 18
  • Not affiliated with Huntsman Cancer Institute
  • Unable to speak or understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Echo Warner, MPH, PhD, SB

    Huntsman Cancer Institute/ University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Echo Warner, MPH, PhD, SB

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations