Supportive Care Intervention for Outpatient Stem Cell Transplant Patients

A Randomized Controlled Trial of an Avatar-based Supportive Care Intervention for Patients Undergoing Outpatient Stem Cell Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Behavioral: care.coach Avatar™

Detailed Description

Allogeneic hematopoietic stem cell transplantation (HCT) is the delivery of multipotent donor-derived stem cells to a recipient patient. It typically involves a lengthy inpatient hospitalization (median 25.8 days). With improving availability of health services, prophylactic medications, and lower infection risk and transfusion requirements, outpatient HCT is becoming more prevalent for patients receiving reduced intensity conditioning (RIC). However, even for outpatient HCT, patients are hospitalized for a median of 8 days. Most symptoms from HCT are concentrated in the first 30-days after the transplant, and these must be better addressed to optimize benefits from outpatient HCT. For patients undergoing HCT, incidence of psychological consequences is higher than in other cancer health states; potential psychological symptoms include stress, anxiety, anger, depression, insomnia, and loneliness. Non-pharmacological approaches for improving quality of life (QOL) and reducing distress among HCT patients include psychoeducational, exercise, and mindfulness interventions. Although post-HCT changes in lifestyle are challenging, the Health Belief Model and Prochaska's Transtheoretical model of change posit that patients preparing for HCT day 0 (notated as D0), when they receive the stem cell infusion, would be highly motivated to learn about psychosocial supports and activities given their readiness for change and taking action. This presents an ideal timeframe for studying a psychosocial health coaching intervention.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chantal M Kerssens, PhD; Phone Number: 404-849-8323; Email: chantal@friendi.fi
• Study Contact Backup: Name: Victor Wang, MS; Phone Number: 415-866-6964; Email: victor@friendi.fi

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Amar H Kelkar, MD; Email: amarh_kelkar@dfci.harvard.edu
      • Principal Investigator: Gregory A Abel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18+
• Seen for outpatient RIC HCT (prior to D0, generally D-6).

Exclusion Criteria:

• Deemed by clinical staff or research assistant (RA) to be unable to converse with an avatar, due to: severe, uncorrectable hearing or vision impairment; severe speech impairment that precludes understanding by staff (or by the avatar).
• Not fluent in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: care.coach Avatar™; 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.
No Intervention: Usual Supportive Care; Traditional supportive care comprising of a binder with HCT educational materials and regular meetings with a transplant nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HADS-A	Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale	Baseline, Day 20 (D+20) post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACT-BMT	Functional Assessment of Cancer Therapy - Bone Marrow Transplantation	Baseline, Day 20 (D+20) post-transplant
HADS-A	Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale	Baseline, Day 90 (D+90) post-transplant
FACT-BMT	Functional Assessment of Cancer Therapy - Bone Marrow Transplantation	Baseline, Day 90 (D+90) post-transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversions	Conversion from Outpatient to Inpatient Transplant	Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant
HADS-D	Hospital Anxiety and Depression Scale (HADS) - Depression subscale	Baseline, Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant

Collaborators and Investigators

• Sponsor: Victor Wang
• Collaborators: Dana-Farber Cancer Institute; care.coach corporation
• Investigators: Principal Investigator: Victor Wang, MS, Friendi.fi Corporation; Study Director: Chantal M Kerssens, PhD, Friendi.fi Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): November 29, 2026

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: health coaching; conversational relational agents
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: DFCI 24-183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No