Clinical trial NCT05600101: Development and Piloting an Avatar-based Intervention to Support Patients Undergoing Stem Cell Transplantation
Official title: Development of Avatar-based Intervention to Support Patients Undergoing Reduced-Intensity Allogenic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Cell Transplantation
Keywords: Reduced intensity conditioning allogeneic transplant
Stem cell transplantation
Avatar-based technology
Artificial intelligence
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-10-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Retained
timeFrame: Baseline to 3 weeks
Secondary outcomes:
measure: Final Cohort Dissatisfaction Rate
timeFrame: 3 weeks
measure: The Completion Rate Post-Pilot Survey
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Gregory Abel, MPH, MD
role: PRINCIPAL_INVESTIGATOR
References: