Supportive Care Intervention for Outpatient Stem Cell Transplant Patients

NCT06564233 | Recruiting

• 1 other identifier: DFCI 24-183
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic Stem Cell Transplantation; Cancer

Keywords

health coaching; conversational relational agents

Outcome Measures

Primary Outcomes (1)

• HADS-A

  Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale

  Baseline, Day 20 (D+20) post-transplant

Secondary Outcomes (3)

• FACT-BMT

  Baseline, Day 20 (D+20) post-transplant

• HADS-A

  Baseline, Day 90 (D+90) post-transplant

• FACT-BMT

  Baseline, Day 90 (D+90) post-transplant

Other Outcomes (2)

• Conversions

  Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant

• HADS-D

  Baseline, Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant

Study Arms (2)

care.coach Avatar™

EXPERIMENTAL

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™

Usual Supportive Care

NO INTERVENTION

Traditional supportive care comprising of a binder with HCT educational materials and regular meetings with a transplant nurse.

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.

care.coach Avatar™

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: collaborator
• care.coach corporation: collaborator
• Victor Wang: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Victor Wang, MS

  Friendi.fi Corporation

  PRINCIPAL INVESTIGATOR

• Chantal M Kerssens, PhD

  Friendi.fi Corporation

  STUDY DIRECTOR

Central Study Contacts

Chantal M Kerssens, PhD

CONTACT

404-849-8323; chantal@friendi.fi

Victor Wang, MS

CONTACT

415-866-6964; victor@friendi.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-founder, President

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)