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

Embodied Conversational Agent (ECA) as an Oncology Trial Advisor

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Patient Compliance; Guideline Adherence
• Intervention / Treatment: Behavioral: Chemo Buddy

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. speaks English fluently
2. is able to independently consent into this study and parent cancer study
3. has adequate corrected vision to use the ECA system (based on a 1-minute functional screener)
4. has adequate hearing to use the ECA system

Exclusion Criteria:

1. suicidal or homicidal
2. currently in police custody
3. do not live in the Boston area
4. plan on leaving the Boston area for more than 4 weeks in the next 6 months
5. score 6 or less on the SPMSQ screening test

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care for chemotherapy treatment.
Experimental: Chemo Buddy; Subject receives instructions on how to use the personalized touch screen tablet and takes it home for 2 months.	Behavioral: Chemo Buddy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Cancer Institute (NCI); Northeastern University
• Investigators: Principal Investigator: Michael Paasche-Orlow, MD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: H-34989; 5R01CA158219-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No