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

Hematopoietic Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600101
• Other study ID #: 22-412
• Secondary ID: R44CA236253
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: May 16, 2023

Study information

• Verified date: September 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 16, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematopoietic Cell Transplantation

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification of care.coach	The objective of the focus group is to identify key educational topics of interest, frequency of check-ins with the study patients, transplant treatment groups most likely to benefit from the avatar.	1 day
Primary	Patient Retention	Retaining 18 patients of the protocol from enrollment to hospital discharge or 3 weeks from enrollment (whichever is earlier).	Baseline to 3 weeks
Secondary	Patient Satisfaction Rate	Patient satisfaction rate of 80% in the third 6-patient cohort.	3 weeks
Secondary	Rate of Completion of the HCT Educational Modules	Rate of completion of HCT educational modules of 75%.	3 weeks
Secondary	The Completion Rate Post-Pilot Survey	Rate of completion of post-pilot survey within 1 week of discharge of 90%.	3 weeks