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

Not Applicable

Completed

• Conditions: Hematopoietic Cell Transplantation
• Interventions: Behavioral: Care.Coach

• Registration Number: NCT05600101
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Study Start: 2022-12-06
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-16
• Results First Submitted: 2024-04-08
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
care.coach Pilot	Care.Coach	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States