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SAFE.AI: Developing and Testing an AI-based Hybrid Chatbot for Financial Empowerment in Rural Cancer Care

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status

Not yet enrolling

Conditions

Financial Toxicity
Cancer

Treatments

Other: Rule-Based Chatbot
Other: Hybrid Chatbot

Study type

Interventional

Funder types

Other

Identifiers

NCT07410689
HCI193501

Details and patient eligibility

About

This is a randomized, two-arm, parallel-group pilot trial investigating a new chatbot tool designed to support cancer patients and caregivers, particularly those in rural communities. Approximately 60 participants will be randomized 1:1 to interact with either a hybrid chatbot or an AI-enabled chatbot. Participants will use their assigned chatbot to obtain clear and helpful information related to insurance, travel costs, and other financial aspects of cancer care.

Full description

Costs of cancer care will approach $246 billion by 2030, making cancer one of the most expensive health conditions for individuals. Cancer-related financial hardships negatively impacts psychological wellbeing, health-related quality of life, medication adherence, and decisions to delay or forgo care. Rural cancer patients and families have a higher prevalence of financial hardships, incur greater travel-related expenses, face unique employment and income stressors, and have lower access to specialized cancer care services and providers-- including those that support financial needs.

Few financial toxicity interventions are designed for the needs of rural cancer patients and families. While financial navigation can effectively reduce cancer patients' out-of-pocket costs, cancer programs' financial and rural patient navigation services, including at the Huntsman Cancer Institute (HCI), are overstrained. Most centers respond to financial hardships reactively rather than proactively, and programs are less equipped to assist with non-medical sources of cancer costs, such as travel and employment hardships.

To address this gap, Self-Advocacy for Financial Empowerment (SAFE) resource toolkit with a community advisory board consisting of rural cancer patients, caregivers, and healthcare stakeholders. Community-engaged research also identified the need for individualized and accessible information about financial resources and supports, stigma as a barrier to seeking help, and the time and resource-intensive nature of financial navigation that limits the penetration and reach of these essential services among rural communities impacted by cancer.

Chatbots, or conversational agents, are a type of artificial intelligence (AI) system that applies machine learning to reproduce realistic human conversations. Scripted chatbots, based on clearly defined information boundaries, offer accurate, reliable, and individualized responses to questions. Conversely, AI-based chatbots that use large language models (LLM) like GPT4, can address ambiguous, open-ended questions while continuing to preserve privacy. Chatbots facilitate individualized, chunked information that enhances complex information communication, promotes users' privacy and support needs, and addresses workforce challenges.[

GARDE-Chat, an open-source platform, has been established for health system-level risk assessment and genetic testing for hereditary cancer at HCI. GARDE-Chat supports scripted, hybrid, and AI-chatbots. Prior to this pilot test, GARDE-Chat will be used to create a chatbot designed to provide responses for financial toxicity, based on the SAFE toolkit content and verified resources to develop the scripted version of the chatbot. A large language model component of the chatbot will be incorporated for the hybrid version that will enable users to ask more complex and open-ended questions, refined with community stakeholder input.

This is a randomized, two-arm, parallel-group pilot trial investigating a new chatbot tool designed to support cancer patients and caregivers, particularly those in rural communities. Approximately 60 participants will be randomized 1:1 to interact with either a hybrid chatbot or an AI-enabled chatbot. Participants will use their assigned chatbot to obtain clear and helpful information related to insurance, travel costs, and other financial aspects of cancer care. Enrolled participants will complete three surveys (pretest, posttest, and 2-week follow-up) and interact with the chatbot prior to the posttest. Participants can interact with the chatbot between the posttest and the 2-week followup as they choose. Participants will share feedback on the usefulness, ease of use, and overall experience using the chatbot and complete pre-and posttest measures to assess preliminary efficacy for secondary outcome measures. All research activities will be done online.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults (18 years and older)
  • Cancer patients or financially responsible caregivers of cancer patients who:
  • Reside in the Huntsman Cancer Institute's five-state catchment area (Utah, Idaho, Wyoming, Montana, and Nevada),
  • Are able to read and write in English, and
  • Live in a rural area, defined by endorsement of a residential ZIP code classified as non-metropolitan (RUCA codes 4-10) per the USDA Rural-Urban Commuting Area Codes.

Exclusion criteria

  • Respondents who do not live within this 5-state region--The SAFE toolkit material was developed for the Huntsman Cancer Institute patient population which serves UT, ID, MT, WY, & NV
  • Respondents who only speak Spanish or other exclusively non-English speaking groups--The large language model for the chatbot will be developed in the English language. As non-English language training for the chatbot is not part of the scope of this study, participants who are unable to read and write in English may not be appropriate. As such, we will not be recruiting participants who only speak Spanish or other exclusively non-English speaking groups. Future studies will include adaptation of the chatbot to other languages.
  • Caregivers who are not primarily responsible for the financial aspects of patients' cancer care--The topic of financial hardship of cancer care may be less relevant for caregivers who are not financially involved in care.
  • Non-rural dwelling

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Rule-based Chatbot
Other group
Description:
Participants randomized to this arm will be asked to use the rule-based chatbot.
Treatment:
Other: Rule-Based Chatbot
Hybrid Chatbot
Other group
Description:
Participants randomized to this arm will be asked to use the hybrid chatbot
Treatment:
Other: Hybrid Chatbot

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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