Study Buddy (an ECA Oncology Trial Advisor) for Cancer Trials

Study Overview
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Brief Summary
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The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting protocol adherence and retention, providing anticipatory guidance and answering questions, serving as a conduit to capture information about complaints or adverse events, providing a venue for communicating about updates. The Study Buddy will use the web-based ECA infrastructure developed for use on another project. We will use web browsers on tablets provided to study participants to access the Study Buddy, providing anywhere, anytime access to its functions. Usability metrics will include session time, satisfaction, and error rates.

Detailed Description
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Subjects will be identified from among patients on chemotherapy regimens at BMC. With the provider's approval, we will recruit patients for this study. All subjects will be enrolled for 2 months. After consent, we will collect baseline data. Baseline data is collected after enrollment and before randomization. Baseline data includes: sociodemographic data PROMIS Mental and Social health the PHQ-9 clinical factors such as medical diagnosis (cancer type and stage) the Short Assessment of Health Literacy-English the Short Portable Mental Status Questionnaire (SPMSQ) for cognitive impairment the Need For Cognition scale contact numbers of two friends or family members who will assist us in establishing contact, if necessary. The exit interview will be conducted 2 months after the baseline interview, with windows of 2 weeks plus or minus that date. Study staff will attempt to coincide this interview with a clinical visit, to minimize inconvenience for the subject. Data collected at the exit interview will include: PROMIS Mental and Social health the PHQ-9 Satisfaction with ECA Review of the subject's medical chart will be performed bi-weekly while the subject is enrolled. Chart review will be performed by a staff member who is blinded to the subject's group (intervention vs control).

Official Title
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Embodied Conversational Agent (ECA) as an Oncology Trial Advisor

Conditions
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Patient Satisfaction, Patient Compliance, Guideline Adherence

Intervention / Treatment
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* Behavioral: Chemo Buddy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: speaks English fluently is able to independently consent into this study and parent cancer study has adequate corrected vision to use the ECA system (based on a 1-minute functional screener) has adequate hearing to use the ECA system Exclusion Criteria: suicidal or homicidal currently in police custody do not live in the Boston area plan on leaving the Boston area for more than 4 weeks in the next 6 months score 6 or less on the SPMSQ screening test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard of care for chemotherapy treatment. | |
| Experimental: Chemo Buddy<br>Subject receives instructions on how to use the personalized touch screen tablet and takes it home for 2 months. | Behavioral: Chemo Buddy<br>* The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting protocol adherence and retention, providing anticipatory guidance and answering questions, serving as a conduit to capture information about complaints or adverse events, providing a venue for communicating about updates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment protocol adherence | How well does the subject adhere to treatment protocol. This will be defined by the number of treatment visits attended/ number of treatment visits scheduled [excluding any treatment visits that have been cancelled by the clinicians]. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | assessed by questionnaire | assessed at 2 months | 
| Number of adverse events | as reported through tablet and directly to clinic by patient | assessed at 2 months | 
| time to detect and resolve adverse events | as reported through tablet and directly to clinic by patient | assessed at 2 months | 
| adverse event false alarm rate | as reported through tablet and directly to clinic by patient | assessed at 2 months |