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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematopoietic Cell Transplantation

Intervention / Treatment
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* Behavioral: Care.Coach


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: care.coach Pilot<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Rate | Patient satisfaction rate of 80% in the third 6-patient cohort. | 3 weeks | 
| Rate of Completion of the HCT Educational Modules | Rate of completion of HCT educational modules of 75%. | 3 weeks | 
| The Completion Rate Post-Pilot Survey | Rate of completion of post-pilot survey within 1 week of discharge of 90%. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reduced intensity conditioning allogeneic transplant, Stem cell transplantation, Avatar-based technology, Artificial intelligence