Supportive Care Intervention for Outpatient Stem Cell Transplant Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Victor Wang
Study ID
NCT06564233
Status
Recruiting

Conditions

  • Cancer
  • Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • care.coach Avatar™ — BEHAVIORAL
    care.coach Avatar™ ("avatar") is a conversational relational agent that serves as a virtual companion and appears on a tablet device as an animated pet avatar. Each avatar is supervised by a 24x7 remote team of trained human staff whose abilities are augmented by artificial intelligence (AI) and software-driven health coaching and clinical protocols for consistency, automation, and scale. This unique human-in-the-loop design enables safe, empathic, natural conversations that form the basis for trusting relations and lasting behavior change. In addition to being a companion, the avatar educates patients about their condition, helps manage symptoms, and reinforces other healthy habits. Independent studies have demonstrated improved outcomes at a reduced cost of care. A pilot study demonstrated the feasibility of care.coach Avatar™ as a psychosocial support and health coach in hospitalized HCT patients. More research is needed to assess efficacy and applications in other HCT settings.

Study Details

The overall goal of this study is to assess the efficacy of the care.coach Avatar™ in improving anxiety and quality of life for patients undergoing outpatient transplant. After care.coach Avatar™ content and scheduling ("digital intervention" or "program") has been optimized for outpatient allogeneic hematopoietic stem cell transplantation (HCT), a randomized controlled trial (RCT) will be conducted of the digital versus usual supportive care program for outpatient HCT recipients. Potential improvements in anxiety and quality of life will be evaluated, with the intent of increasing comfortability with outpatient transplant and expanding the population of eligible patients willing to receive their transplants in an outpatient setting.

Key Dates

Start date
Oct 21, 2024
Status verified
Mar 2026
Primary completion
Sep 20, 2026
Completion
Nov 29, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: care.coach Avatar™
    care.coach Avatar™ with usual supportive care. The avatar program includes companionship, HCT educational modules, relaxation and mindfulness exercises, simple (seated) physical exercises, nightly check ins, and symptom self-management as needed.
  • No Intervention: Usual Supportive Care
    Traditional supportive care comprising of a binder with HCT educational materials and regular meetings with a transplant nurse.

Primary Outcome Measure

HADS-A [ Time Frame: Baseline, Day 20 (D+20) post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Amar H Kelkar, MD
Gregory A Abel, MD (PRINCIPAL_INVESTIGATOR)

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