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NCT Number: NCT06564233

Supportive Care Intervention for Outpatient Stem Cell Transplant Patients

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Amar H Kelkar, MD

CONTACT

[email protected]

Gregory A Abel, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. HADS-A

    Time frame: Baseline, Day 20 (D+20) post-transplant

    Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale

Secondary outcomes

  1. FACT-BMT

    Time frame: Baseline, Day 20 (D+20) post-transplant

    Functional Assessment of Cancer Therapy - Bone Marrow Transplantation

  2. HADS-A

    Time frame: Baseline, Day 90 (D+90) post-transplant

    Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale

  3. FACT-BMT

    Time frame: Baseline, Day 90 (D+90) post-transplant

    Functional Assessment of Cancer Therapy - Bone Marrow Transplantation

Other outcomes

  1. Conversions

    Time frame: Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant

    Conversion from Outpatient to Inpatient Transplant

  2. HADS-D

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

    Hospital Anxiety and Depression Scale (HADS) - Depression subscale

Study contacts

Contact information is provided by the study sponsor or research team.

Chantal M Kerssens, PhD

CONTACT

[email protected]

404-849-8323

Victor Wang, MS

CONTACT

[email protected]

415-866-6964

Sponsors and collaborators

Lead sponsor

Victor Wang

Industry

Collaborators

  • Dana-Farber Cancer Institute
  • care.coach corporation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Mar 6, 2026

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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