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Completed

NCT Number: NCT05600101

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants Retained

    Time frame: 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 outcomes

  1. Final Cohort Dissatisfaction Rate

    Time frame: 3 weeks

    Percent of patients dissatisfied with the avatar in the third 6-patient cohort.

  2. The Completion Rate Post-Pilot Survey

    Time frame: 3 weeks

    Rate of completion of post-pilot survey within 1 week of discharge

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Development of Avatar-based Intervention to Support Patients Undergoing Reduced-Intensity Allogenic Stem Cell Transplantation

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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