AI-Driven Survivorship Care Plans (AI-SCP) (AI-SCP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: SCP Chatbot

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Echo Warner, MPH, PhD, SB; Phone Number: 801-244-7040; Email: echo.warner@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
      • Principal Investigator: Echo Warner, MPH, PhD, SB
      • Contact: Echo Warner, MPH, PhD, SB; Phone Number: 801-244-7040; Email: u0600488@umail.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SCP Chatbot; Participants will receive an AI-SCP and access to the SCP chatbot from an oncologist for 7 days .	Other: SCP Chatbot; 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; Other Names: GARDE-Chat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability/Usability: System Usability Scale	Acceptability and usability of the interactive AI-SCP and chatbot. This outcome measure will report the mean System Usability Scale (SUS) score. SUS scores range from 0-100, with higher scores indicating better usability and lower scores indicating worse usability.	up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS Anxiety	To assess preliminary patient-level effects of the interactive AI-SCP and chatbot. This outcome measure will report mean change in PROMIS Anxiety T-scores. PROMIS Anxiety 4a - Adult v1.0 Scores range from 40.3 to 81.6, with lower scores indicating less anxiety and higher scores indicating more anxiety.	up to 7 days
Change in Cancer Worry Scale	To assess preliminary patient-level effects of the interactive AI-SCP and chatbot. The Cancer Worry Scale (CWS) uses a 4-point Likert scale to measure cancer-related worry. This outcome measure will report the mean change in CWS score. CWS scores range from 8 to 32, with lower scores indicating less worry and higher scores indicating greater worry.	up to 7 days

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Huntsman Cancer Institute
• Investigators: Principal Investigator: Echo Warner, MPH, PhD, SB, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HCI201667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No