CancerECA-PRO Aim 3NCT05948618
Improving PRO for Patients With Cancer Using ECAs and Data Visualization
A study testing Embodied Conversational Agent and REDCap Survey in people with Cancer, run by Tufts Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Embodied Conversational Agent and REDCap Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age or older
- Able to read and speak english
- 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.
- Has a diagnosis of gastrointestinal cancer or head and neck cancer for which they are currently receiving chemotherapy and/or radiation treatment.
- Provider subjects must be practicing oncologists at BMC.
Who cannot join
- If the subject is incarcerated
- If the subject plans to leave the Boston area in the next 6 weeks
- Is not able to use the ECA screener
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving PRO Interpretation at the Individual Level for Patients With Cancer Using Conversational Agents and Data Visualization - Aim 3
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.
Read the detailed description
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 goal of this study is to adapt our prior work on ECAs to produce ECA-PRO, a framework for administering PROs over time using an ECA. ECA-PRO will be used to administer PROs from the Patient-Reported Outcomes Measurement Information System (PROMIS), as well as measures from the Common Terminology Criteria for Adverse Events (CTCAE). The plan is to administer PROMIS measures relevant to cancer including physical functioning, fatigue, depression, anxiety, and pain interference. This study will test the system in an RCT with 100 patients receiving chemotherapy and/or radiation therapy for gastrointestinal or head and neck cancer. Participants will be randomized to provide data for 6 weeks using ECA-PRO (n=50) versus standard web administration (REDCap) (n=50).
- Conditions
- Cancer
- Being tested
- Embodied Conversational Agent, REDCap Survey
- Keywords
- cancer, patient reported outcomes, medication adherence
- Medical subject headings
- Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embodied Conversational AgentBehavioural
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.
REDCap SurveyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Embodied Conversational Agent | Experimental | 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. Receives: Behavioral: Embodied Conversational Agent |
| RedCap Survey | Active comparator | 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 Receives: Behavioral: REDCap Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of missing data will be investigated to gauge the extent to which patients are actively engaging with the ECA-PRO system.
Assessing the completeness of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey questions, 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.
Measured: 6 weeks
Secondary outcomes (7)
Physical function
There will be items from the PRO-CTCAE survey questions, that will ask participants to report the frequency of their symptoms related to their physical functioning. Participants will fill out this survey with the ECA or in REDCap (depending on the intervention participants are receiving).
Measured: 6 weeks
Fatigue
There will be items from the PRO-CTCAE survey questions, that will ask participants to report the frequency of their symptoms related to fatigue. Participants will fill out this survey with the ECA or in REDCap (depending on the intervention participants are receiving).
Measured: 6 weeks
Depression
There will be items from the PRO-CTCAE survey questions, that will ask participants to report the frequency of their depression symptoms. Participants will fill out this survey with the ECA or in REDCap (depending on the intervention participants are receiving).
Measured: 6 weeks
Anxiety
There will be items from the PRO-CTCAE survey questions, that will ask participants to report the frequency of their anxiety symptoms. Participants will fill out this survey with the ECA or in REDCap (depending on the intervention participants are receiving).
Measured: 6 weeks
Pain Interference
There will be items from the PRO-CTCAE survey questions, that will ask participants to report the frequency of pain interference. Participants will fill out this survey with the ECA or in REDCap (depending on the intervention participants are receiving).
Measured: 6 weeks
Sleep Disturbance
There will be items from the PRO-CTCAE survey questions, that will ask participants to report the frequency of their sleep disturbance. Participants will fill out this survey with the ECA or in REDCap (depending on the intervention participants are receiving).
Measured: 6 weeks
Ability to participate in social roles and activities
There will be items from the PRO-CTCAE survey questions, that will ask participants to report the frequency of their pain and how it impacts their ability to participate in social roles and activities. Participants will fill out this survey with the ECA or in REDCap (depending on the intervention participants are receiving).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start24 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael Paasche-Orlow, MD, MPH, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948618
- Sponsor's protocol ID
- H-44542
- Acronym
- ECA-PRO Aim 3
- Status last verified
- Mar 2026
- First submitted
- 19 May 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving PRO Interpretation at the Individual Level for Patients With Cancer Using Conversational Agents and Data Visualization - Aim 3
- ClinicalTrials.gov ID
- NCT05948618
- Acronym / sponsor ID
- ECA-PRO Aim 3 / H-44542
- Conditions
- Cancer
- Keywords
- cancer, patient reported outcomes, medication adherence
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Boston Medical Center
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 goal of this study is to adapt our prior work on ECAs to produce ECA-PRO, a framework for administering PROs over time using an ECA. ECA-PRO will be used to administer PROs from the Patient-Reported Outcomes Measurement Information System (PROMIS), as well as measures from the Common Terminology Criteria for Adverse Events (CTCAE). The plan is to administer PROMIS measures relevant to cancer including physical functioning, fatigue, depression, anxiety, and pain interference. This study will test the system in an RCT with 100 patients receiving chemotherapy and/or radiation therapy for gastrointestinal or head and neck cancer. Participants will be randomized to provide data for 6 weeks using ECA-PRO (n=50) versus standard web administration (REDCap) (n=50).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embodied Conversational Agent | Experimental | Behavioral: Embodied Conversational AgentThe 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. |
| RedCap Survey | Active comparator | Behavioral: REDCap SurveyAn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age or older
- Able to read and speak english
- 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.
Key exclusion criteria (3 listed)
- If the subject is incarcerated
- If the subject plans to leave the Boston area in the next 6 weeks
- Is not able to use the ECA screener
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embodied Conversational AgentThe 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. | Behavioural | Embodied Conversational Agent |
| REDCap SurveyAn 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 | Behavioural | RedCap Survey |
Primary outcome
The degree of missing data will be investigated to gauge the extent to which patients are actively engaging with the ECA-PRO system.
Time frame: 6 weeks
Assessing the completeness of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey questions, 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.
7 secondary outcomes
Physical function
Time frame: 6 weeks
Fatigue
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Anxiety
Time frame: 6 weeks
Pain Interference
Time frame: 6 weeks
Sleep Disturbance
Time frame: 6 weeks
Ability to participate in social roles and activities
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Paasche-Orlow, MD, MPH principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embodied Conversational Agent and REDCap Survey in people with Cancer, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of missing data will be investigated to gauge the extent to which patients are actively engaging with the ECA-PRO system. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.