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

NCT ID: NCT05600101

Last Updated: 2024-07-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2023-05-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hematopoietic Cell Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Care.Coach

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gregory A. Abel, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gregory Abel, MPH, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R44CA236253

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-412

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Rehabilitation in HCT
NCT05943964 RECRUITING NA
Multimodal Sexual Dysfunction Intervention In HCT
NCT03803696 ACTIVE_NOT_RECRUITING NA