Development and Piloting an Avatar-based Intervention to Support Patients Undergoing Stem Cell Transplantation

Development of Avatar-based Intervention to Support Patients Undergoing Reduced-Intensity Allogenic Stem Cell Transplantation

The goal of this research study is to provide an avatar-based technology during a subject's stay for participants who have been admitted to the hospital for reduced-intensity conditioning (RIC) allogeneic transplant. The intervention received will be the care.coach technology.

Study Overview

• Status: Completed
• Conditions: Hematopoietic Cell Transplantation
• Intervention / Treatment: Behavioral: Care.Coach

Detailed Description

This research study is a Pilot Study, which means the investigators are studying the application in a smaller group of people to understand whether the technology, care.coach, is easy to use.

This is a single site study at Dana-Farber Brigham and Women's Cancer Center.

• Aim 1 of the study will be an 8 - 10 participant focus group of nurses, navigator nurses, physicians, and NPs/PAs to refine the avatar protocols.

• Aim 2 of the study will be a pilot of 18 participants undergoing RIC allogeneic HCT in the hospital.

  • The research study procedures include screening for eligibility, a brief call with a research assistant during use of care.coach avatar, and a survey after study completion.
  • The avatar is designed to communicate with participants regarding transplantation education and provide reminders for eating, drinking, and activity.
  • care.coach is a digital, avatar-based technology that communicates using natural speech software.
  • care.coach is supporting this research by providing Dana-Farber access to its technology. The National Cancer Institute (NCI) also supports this research.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for HCT focus group:

• Age 18+.
• DFCI/HCC HCT nurse navigators, inpatient HCT nurses, and HCT physicians and extenders (NP/PA).

Inclusion Criteria for care.coach pilot:

• Age 18+.
• Admitted for reduced-intensity conditioning (RIC) allogeneic HCT

Exclusion Criteria for care.coach pilot:

Deemed by clinical staff or RA to be unable to converse with an avatar, due to:

• Severe, uncorrectable hearing impairment and simultaneous severe, uncorrectable vision impairment.
• Severe speech impairment that precludes understanding by staff (and by extension, by the avatar).
• Not fluent in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: care.coach Pilot; The research study procedures include screening for eligibility, a brief call with a research assistant after tablet is given to subject, and a survey after a subject has completed the study.; 3 consecutive cohorts of 6 RIC HCT patients each.; care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates. A subject uses the avatar for up to 3 weeks.

Behavioral: Care.Coach; Care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Retained	Participants complete study protocol, including post-completion survey, from enrollment to hospital discharge or 3 weeks from enrollment (whichever is earlier).	Baseline to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final Cohort Dissatisfaction Rate	Percent of patients dissatisfied with the avatar in the third 6-patient cohort.	3 weeks
The Completion Rate Post-Pilot Survey	Rate of completion of post-pilot survey within 1 week of discharge	3 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gregory Abel, MPH, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Artificial intelligence; Stem cell transplantation; Reduced intensity conditioning allogeneic transplant; Avatar-based technology
• Other Study ID Numbers: 22-412; R44CA236253 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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