Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44CA236253 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| care.coach Pilot | Experimental | 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.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care.Coach | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Final Cohort Dissatisfaction Rate | Percent of patients dissatisfied with the avatar in the third 6-patient cohort. | 3 weeks |
| The Completion Rate Post-Pilot Survey | Rate of completion of post-pilot survey within 1 week of discharge |
Not provided
Inclusion Criteria for HCT focus group:
Inclusion Criteria for care.coach pilot:
Exclusion Criteria for care.coach pilot:
Deemed by clinical staff or RA to be unable to converse with an avatar, due to:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory Abel, MPH, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Not provided
There were no significant events in the study for any patients between their enrollment and assignment to an arm or group of the study.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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.
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. |
| FG001 | 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. The group consisted of of 2 bedside registered nurses, 1 oncology nurse, 3 transplant physicians, 1 physical therapist, 1 transplant nurse practitioner, 1 physician assistant transplant educator, and 1 nurse transplant educator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
care.coach Pilot arm participants were patients admitted for inpatient RIC HCT. AI HCT Focus Group arm participants were HCT clinicians. Demographics cannot be reported for the AI HCT Focus Group arm participants as it was an anonymous focus group. No post-baseline Primary and Secondary Outcome Measure data were collected the AI HCT Focus Group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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.
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | AI HCT Focus Group participant demographics were not analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | Baseline to 3 weeks |
|
For the care.coach Pilot arm participants, their adverse event data was collected from enrollment to hospital discharge or 3 weeks from enrollment (whichever was earlier). Adverse Events were not monitored or assessed for AI HCT Focus Group arm participants because there was no intervention.
The definitions of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov definitions for the care.coach Pilot arm. Adverse Event data were not collected for the AI HCT Focus Group arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.
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. |
Not provided
Not provided
This is a small cohort so results may need to be confirmed in a larger cohort
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Abel | Dana-Farber Cancer Institute | (877) 442-3324 | Gregory_Abel@dfci.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2022 | Apr 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 17, 2023 | Apr 8, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 weeks |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | AI HCT Focus Group Participants demographics were not analyzed. | Count of Participants | Participants |
|
| Race (NIH/OMB) | AI HCT Focus Group participants demographics were not analyzed | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Final Cohort Dissatisfaction Rate | Percent of patients dissatisfied with the avatar in the third 6-patient cohort. | Posted | Number | percentage of particpants | 3 weeks |
|
|
|
| Secondary | The Completion Rate Post-Pilot Survey | Rate of completion of post-pilot survey within 1 week of discharge | Posted | Number | Survey Completion Rate Percentage | 3 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Focus Group Participants | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|