NCT05600101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 6, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

October 26, 2022

Results QC Date

April 8, 2024

Last Update Submit

June 6, 2024

Conditions

Hematopoietic Cell Transplantation

Keywords

Reduced intensity conditioning allogeneic transplantStem cell transplantationAvatar-based technologyArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Final Cohort Dissatisfaction Rate

    3 weeks

  • The Completion Rate Post-Pilot Survey

    3 weeks

Study Arms (1)

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. * 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

Interventions

Care.CoachBEHAVIORAL

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.

care.coach Pilot

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18+.
  • DFCI/HCC HCT nurse navigators, inpatient HCT nurses, and HCT physicians and extenders (NP/PA).
  • Age 18+.
  • Admitted for reduced-intensity conditioning (RIC) allogeneic HCT

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Limitations and Caveats

This is a small cohort so results may need to be confirmed in a larger cohort

Results Point of Contact

Title
Dr. Gregory Abel
Organization
Dana-Farber Cancer Institute
Gregory_Abel@dfci.harvard.edu
(877) 442-3324

Study Officials

  • Gregory Abel, MPH, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

December 6, 2022

Primary Completion

May 10, 2023

Study Completion

May 16, 2023

Last Updated

July 3, 2024

Results First Posted

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US(2)