Hematopoietic Cell Transplantation
Conditions
Keywords
Reduced intensity conditioning allogeneic transplant, Stem cell transplantation, Avatar-based technology, Artificial intelligence
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.
Interventions
BEHAVIORALCare.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.
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted by a trained research assistant (RA) utilizing HIPAA-compliant and DFCI IRB approved patient approach procedures. A total of 18 participants were consented. Patients were approached and consented upon inpatient admission for RIC HCT. Patients were consented beginning on 12/6/2022 through 5/3/2023.
Pre-assignment details
There were no significant events in the study for any patients between their enrollment and assignment to an arm or group of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 18 |
| AI HCT Focus Group A structured focus group arm consisted of HCT nurse navigators, inpatient HCT nurses, and HCT physicians. Participants provided their perspectives on patient facing artificial intelligence technology which was used to inform care.coach software protocols. Participation was limited to a single 60 minute focus group. | 10 |
| Total | 28 |
Baseline characteristics
| Characteristic | Care.Coach Pilot | Total | AI HCT Focus Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 7 Participants | 7 Participants | — |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | — |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | — |
| Race (NIH/OMB) White | 13 Participants | 13 Participants | — |
| Region of Enrollment United States | 18 Participants | 28 Participants | 10 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | — |
| Sex: Female, Male Male | 7 Participants | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 0 |
| other Total, other adverse events | 0 / 18 | 0 / 0 |
| serious Total, serious adverse events | 0 / 18 | 0 / 0 |
Outcome results
Primary
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).
Time frame: Baseline to 3 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Care.Coach Pilot | Number of Participants Retained | 18 Participants |
Secondary
Final Cohort Dissatisfaction Rate
Percent of patients dissatisfied with the avatar in the third 6-patient cohort.
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Care.Coach Pilot | Final Cohort Dissatisfaction Rate | 0 percentage of particpants |
Secondary
The Completion Rate Post-Pilot Survey
Rate of completion of post-pilot survey within 1 week of discharge
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Care.Coach Pilot | The Completion Rate Post-Pilot Survey | 72 Survey Completion Rate Percentage |