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

Overview

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.

Detailed 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.

Interventions

• Other Rule-Based Chatbot
  The rule-based (scripted) SAFE.ai chatbot is a guided conversational tool built to provide structured, accurate, and consistent information to rural cancer patients and caregivers experiencing cancer-related financial toxicity. This chatbot is grounded in the Self-Advocacy for Financial Empowerment (SAFE) resource toolkit, which was co-developed with a community advisory board (CAB) composed of rural patients, caregivers, nurses, and financial navigation experts across HCI's five-state catchmen
• Other Hybrid Chatbot
  The hybrid SAFE.ai chatbot builds on the existing rule-based system by integrating a large language model (LLM) layer to support more flexible, open-ended, and conversational interactions. While the rule-based chatbot provides structured conversations through predefined content, the hybrid approach allows users to ask complex or personalized questions about financial toxicity. To ensure safety and accuracy, the hybrid chatbot is not allowed to generate responses from the open internet. By comb

Primary outcome measures

• Single-Item Helpfulness Rating [Time frame: up to 2 weeks]
• System Usability Scale (SUS) [Time frame: up to 2 weeks]
• Acceptability of Intervention Measure (AIM) [Time frame: up to 2 weeks]
• Chatbot User Satisfaction (CUS) - Satisfaction Subscale [Time frame: up to 2 weeks]
• Trust in Automated Systems Test (TOAST) [Time frame: up to 2 weeks]

Secondary outcome measures (5)

• Self-reported Financial Worry [Time frame: up to 2 weeks]
• Health-Related Quality of Life (QOL) [Time frame: up to 2 weeks]
• Self-Efficacy for Coping with Cancer [Time frame: up to 2 weeks]
• Psychosocial Distress [Time frame: up to 2 weeks]
• User Engagement with SAFE.AI [Time frame: up to 2 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Huntsman Cancer Institute/ University of Utah — Salt Lake City

Publications

• Mariotto AB, Enewold L, Zhao J, Zeruto CA, Yabroff KR. Medical Care Costs Associated with Cancer Survivorship in the United States. Cancer Epidemiol Biomarkers Prev. 2020 Jul;29(7):1304-1312. doi: 10.1158/1055-9965.EPI-19-1534. Epub 2020 Jun 10. PMID 32522832
• Carrera PM, Kantarjian HM, Blinder VS. The financial burden and distress of patients with cancer: Understanding and stepping-up action on the financial toxicity of cancer treatment. CA Cancer J Clin. 2018 Mar;68(2):153-165. doi: 10.3322/caac.21443. Epub 2018 Jan 16. PMID 29338071
• Lyman GH, Kuderer N. Financial Toxicity, Financial Abuse, or Financial Torture: Let's Call It What It is! Cancer Invest. 2020 Mar;38(3):139-142. doi: 10.1080/07357907.2020.1735084. Epub 2020 Mar 4. No abstract available. PMID 32093505
• Pisu M, Henrikson NB, Banegas MP, Yabroff KR. Costs of cancer along the care continuum: What we can expect based on recent literature. Cancer. 2018 Nov 1;124(21):4181-4191. doi: 10.1002/cncr.31643. Epub 2018 Oct 17. PMID 30475400
• Yabroff KR, Mariotto A, Tangka F, Zhao J, Islami F, Sung H, Sherman RL, Henley SJ, Jemal A, Ward EM. Annual Report to the Nation on the Status of Cancer, Part 2: Patient Economic Burden Associated With Cancer Care. J Natl Cancer Inst. 2021 Nov 29;113(12):1670-1682. doi: 10.1093/jnci/djab192. PMID 34698839
• Knight TG, Deal AM, Dusetzina SB, Muss HB, Choi SK, Bensen JT, Williams GR. Financial Toxicity in Adults With Cancer: Adverse Outcomes and Noncompliance. J Oncol Pract. 2018 Oct 24:JOP1800120. doi: 10.1200/JOP.18.00120. Online ahead of print. PMID 30355027
• Allcott N, Dunham L, Levy D, Carr J, Stitzenberg K. Financial burden amongst cancer patients treated with curative intent surgery alone. Am J Surg. 2019 Sep;218(3):452-456. doi: 10.1016/j.amjsurg.2019.01.033. Epub 2019 Jan 31. PMID 30771864
• Williams CP, Gallagher KD, Deehr K, Aswani MS, Azuero A, Daniel CL, Ford EW, Ingram SA, Balch AJ, Rocque GB. Quantifying treatment preferences and their association with financial toxicity in women with breast cancer. Cancer. 2021 Feb 1;127(3):449-457. doi: 10.1002/cncr.33287. Epub 2020 Oct 27. PMID 33108023

Identifiers

NCT: NCT07410689 · 193501

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗