Improving PRO for Patients With Cancer Using ECAs and Data Visualization

Study Overview
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Brief Summary
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Over the past decade, the investigators have developed and tested a toll with the potential to enhance PROs at the individual level- embodied conversational agents (ECA), which are computer characters that simulate face-to-face conversation using voice, hand gestures, gaze cues, and other nonverbal behavior. The investigators have successfully used ECAs in behavioral interventions for populations with limited health literacy, elderly patients, and patients with cancer. Face-to-face encounters, in conjunction with written instructions supported by pictures, remains one of the best methods for communicating information in general but is particularly effective for individuals with limited health literacy. The investigators have also demonstrated that ECAs can be used as valid alternatives to standard paper-based surveys for substance use screening, and that the display of empathy for patients and other relational behavior by ECAs leads to increased engagement by patients over time.

Detailed Description
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There is increasing recognition of the important of patient-reported outcomes (PROs) for assessment of health-related quality of life in both research and clinical settings. PROs are especially important for inherently subjective but crucial clinical phenomena such as pain, mood, and fatigue. PROs can also provide valid assessments of health where performance-based objective measures are possible, but cost prohibitive or complicated. Despite much research on PROs, concerns about reliability and validity persist, especially when used at the individual level, particularly among patients who may struggle to understand PRO questions, such as those with low health literacy. Over the past decade, the investigators have developed and tested a tool with the potential to enhance PROs at the individual level - embodied conversational agents (ECA), which are computer characters that simulate face-to-face conversation using voice, hand gestures, gaze cues and other nonverbal behavior. The investigators have successfully used ECAs in behavioral interventions for populations with limited health literacy, elderly patients, and patients with cancer. Face-to-face encounters, in conjunction with written instructions supported by pictures, remains one of the best methods for communicating information in general, but is particularly effective for individuals with limited health literacy. The investigators have also demonstrated that ECAs can be used as valid alternatives to standard paper-based surveys for substance use screening, and that the display of empathy for patients and other relational behavior by ECAs leads to increased engagement by patients over time. The overarching aim is to adapt prior work on ECAs to produce ECA-PRO, a framework for administering PROs over time using an ECA on patients' smartphones. The investigators seek to create the ECA-PRO system including novel user interfaces to optimally communicate PRO results to patients and clinicians using clear data visualizations. To demonstrate the generalizability of ECA-PRO, the investigators will focus on two clinical scenarios that are very different: 1) longitudinal monitoring of symptoms and quality of life in patients undergoing cancer treatment, and 2) monitoring of medication adherence in patients taking long-term oral anti-cancer drugs. The investigators hypothesize that the ECA-PRO system, designed for individual-patient-level interactions and data collection, will improve the reliability, validity, and overall clinical relevance of PROs collected during cancer treatment.

Official Title
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Improving PRO Interpretation at the Individual Level for Patients With Cancer Using Conversational Agents and Data Visualization

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Embodied Conversational Agent
* Behavioral: REDCap Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age or older English or Spanish speaking Can independently consent Must have adequate corrected vision to use the ECA system (based on a 1 minute ECA functional screener) Must have adequate hearing to use the ECA system. Must have a current cancer diagnosis and an oncologist at BMC (Boston Medical Center) Provider subjects must be practicing oncologists at BMC. Exclusion Criteria: None

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embodied Conversational Agent<br>The ECA systems compromises 1) a smartphone based ECA patient interface; 2) clinician authoring tool, to enable new measurement systems to be rapidly configured 3) clinician and patient data visualizations; and 4) a central server with relation database, administrative user interfaces and ability to send asynchronous notifications to users' smartphones. | Behavioral: Embodied Conversational Agent<br>* The ECA- PRO measures will included PROMIS Profile measures, which include depression, anxiety, fatigue, pain intensity, and interference, fatigue, sleep disturbance, physical function, and satisfaction with social roles. In order to reduce boredom and confusion, equivalent forms of different items will be selected from the items pools. In this way, participants are not answering the same questions twice within one session. We hypothesize that scores will a high degree of concordance which will be evaluated using intraclass correlation coefficients (ICC; assuming absolute agreement for a single measure).<br>|
| Active Comparator: RedCap Survey<br>An internet-based measure will use PROMIS Profile measures which will include depression, anxiety, fatigue, pain intensity and interference, sleep disturbance, physical function and satisfaction with social role | Behavioral: REDCap Survey<br>* An internet-based measure will use PROMIS Profile measures which will include depression, anxiety, fatigue, pain intensity and interference, sleep disturbance, physical function and satisfaction with social role<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enhanced user satisfaction among patients | User satisfaction will be analyzed using a Visual Analog Scale. Patients will be asked to indicate their level of satisfaction by marking on a line that corresponds to their subjective judgement. | 6 weeks | 
| The utilization for ECA-PRO as a monitoring tool for medication adherence in patients undergoing oral medication treatment for breast cancer will be implemented | To assess the medication adherence, the 9-item PROMIS Medication Adherence System will be employed. This comprehensive scale will cover domains such as the extent to which medication is taken as prescribed, knowledge regarding the medication regimen, beliefs about medication, ability to remember taking medication, instances of skipping doses due to side effects or feeling better, and considerations related to the cost of medications. | 6 months | 
| The degree of missing data will be investigated to gauge the extent to which patients are actively engaging with the ECA-PRO system. | Specifically, the analysis will focus on assessing the completeness of the 29-item PROMIS profile, taking into account the number of items that have been satisfactorily completed. By examining prevalence of missing data, the investigators aim to infer the level of patient utilization of the ECA-PRO system, thereby shedding light on the extent to which patients are actively participating in the study and providing valuable insight. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function | There will be 4 items from the 29 item PROMIS profile, that will ask participants to rate different aspects of their physical functioning on a scale of 5-1. 5 will be without any difficulty, 1 being unable to do. Participants will fill out this survey with the ECA or in REDCap (depending on the intervention participants are receiving) and rate their physical functioning | 6 weeks | 
| Fatigue | There will be 4 items from the 29 item PROMIS profile, that will ask participants to rate different aspects about fatigue on a scale of 1-5. 1 being never and 5 being always. Participants will fill out this questionnaire and rate the frequency of their fatigue symptoms. This will be done with the ECA or in REDCap (depending on the intervention participants are receiving). | 6 weeks | 
| Depression | There will be 4 items from the 29 item PROMIS profile, that will ask participants to rate different aspects about depression on a scale of 1-5. 1 being never and 5 being always. Participants will fill out this questionnaire and rate the frequency of their depressive symptoms. This will be done with the ECA or in REDCap (depending on the type of intervention the participants are receiving). | 6 weeks | 
| Anxiety | There will be 4 items from the 29 item PROMIS profile, that will ask participants to rate different aspects about anxiety on a scale of 1-5. 1 being never and 5 being always. Participants will fill out this questionnaire and rate the frequency of their anxiety symptoms. This will be done with the ECA or in REDCap (depending on the type of intervention participants are receiving). | 6 weeks | 
| Pain Interference | There will be 4 items from the 29 item PROMIS profile that will ask participants how often they are impacted by pain. The participants will rate these on a scale of 1-5. 1 being not at all, 5 being very much. These will be done either with the ECA or on REDCap (depending on the type of intervention the participants are receiving). | 6 weeks | 
| Sleep Disturbance | There will be 4 items from the 29 item PROMIS profile that will ask participants various aspects about their sleep. The participants will rate these on a scale of 1-5. 1 being not at all, 5 being very much. These will be done either with the ECA or on REDCap. | 6 weeks | 
| Ability to participate in social roles and activities | There will be 4 items from the 29 item PROMIS profile that will ask participants various aspects about their social and daily activities. The participants will rate these on a scale of 5-1. 1 being always, 5 being never. These will be done either with the ECA or on REDCap. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, patient reported outcomes, medication adherence