SAFE.AI: Developing and Testing an AI-based Hybrid Chatbot for Financial Empowerment in Rural Cancer Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (18 years and older)
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Rule-Based Chatbot
Other interventionThe 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 catchment area. All scripted responses reflect priorities identified during qualitative needs assessment sessions, ensuring that content is culturally aligned with rural patient experiences and real-world financial challenges. The chatbot follows a rule-based decision tree. Users progress through the conversation by selecting a response from a set of fixed options displayed on-screen. This ensures that all content is clinically vetted, safe, consistent, and aligned with evidence-based practices.
Hybrid Chatbot
Other interventionThe 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 combining the consistency of rule-based logic with the adaptability of an LLM, the hybrid chatbot will enable users to ask follow-up questions, describe nuanced financial situations, request clarification in their own words, and receive more tailored guidance while still ensuring adherence to SAFE content.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Rule-based ChatbotOther 1 intervention
Group B: Hybrid ChatbotOther 1 intervention
Trial outcomes
Primary outcomes
1
Single-Item Helpfulness Rating
Helpfulness is assessed using a 5-point Likert-scale item with response options ranging from Very unhelpful (1) to Very helpful (5). Total scores range from a minumum of 1 to a maximum of 5, with lower scores indicating lower perceived helpfulness, and higher scores indicating greater perceived helpfulness.
Time frame
up to 2 weeks2
System Usability Scale (SUS)
The SUS is a 10-item, 5 point Likert scale (0 = strongly disagree, 5 = strongly agree). Total scores range from a minimum of 0 to a maximum of 100, with lower values indicating less usability and higher values indicating higher usability.
Time frame
up to 2 weeks3
Acceptability of Intervention Measure (AIM)
The AIM is a 4-item, 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Total scores range from a minimum of 4 a maximum of 20, with lower values indicating lower acceptability and higher values indicating higher acceptability.
Time frame
up to 2 weeks4
Chatbot User Satisfaction (CUS) - Satisfaction Subscale
The Satisfaction subscale of the CUS measure is a 5 item Likert-scale ( 1 = strongly disagree, 5 = strongly agree). Total scores range from a minimum of 5 to a maximum of 25, with lower values indicating lower user satisfaction, and higher values indicating higher satisfaction.
Time frame
up to 2 weeksSecondary outcomes
1
Self-reported Financial Worry
Financial Worry will be assessed by the COST (COmprehensive Score for financial Toxicity) assessment. COST is a 12-item, 5-point Likert scale (0=Not at All to 4 =Very Much). Total scores range from a minimum of 0 to a maximum of 44, with lower scores indicating worse Financial Well-Being and higher scores indicating better Financial Well-Being. This outcome measure will report mean COST score.
Time frame
up to 2 weeks2
Health-Related Quality of Life (QOL)
Health-related quality of life will be assessed with the 36-item short-form Health Survey (SF-36). The SF-36 has two subscales, the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each subscale ranges from 0-100, with lower scores indicating worse QOL and higher scores indicating better QOL. This outcome measure will report the mean PCS and MCS scores.
Time frame
up to 2 weeks3
Self-Efficacy for Coping with Cancer
Self-efficacy for coping with cancer will be assessed with the Cancer Behavior Inventory-Brief Version (CBI-B) questionnaire. CBI-B is a 12-item, 9-point Likert scale (1=Not at All Confident to 9=Totally Confident). Total CBI-B scores range from 9 to 108, with lower scores indicating worse self-efficacy and higher scores indicating better self-efficacy.
Time frame
up to 2 weeks4
Psychosocial Distress
Psychosocial distress will be measured by the Patient Health Questionnaire-4 (PHQ-4). PHQ-4 is a 4-item, 4-point Likert scale (0 = Not at All to 3 = Nearly every day). Total PHQ-4 scores range from 0 to 12, with lower scores indicating less psychosocial distress and higher scores indicating more severe psychosocial distress.
Time frame
up to 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
Huntsman Cancer Institute
Collaborator
Source ClinicalTrials.gov