Improving PRO for Patients With Cancer Using ECAs and Data Visualization

NCT05948618 | Enrolling By Invitation DMC

• 1 other identifier: H-44542
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer

Keywords

cancer; patient reported outcomes; medication adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (7)

• Physical function

  6 weeks

• Fatigue

  6 weeks

• Depression

  6 weeks

• Anxiety

  6 weeks

• Pain Interference

  6 weeks

Study Arms (2)

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.

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

Behavioral: REDCap Survey

Interventions

Embodied Conversational Agent BEHAVIORAL

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.

Embodied Conversational Agent

REDCap Survey BEHAVIORAL

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

RedCap Survey

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Boston Medical Center: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Neoplasms; Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michael Paasche-Orlow, MD, MPH

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The team statistician will be blinded to experimental condition to reduce the possibility of bias. Only after analyses have been completed will the blinds be revealed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: July 17, 2023
• Study Start: November 24, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)