Hematopoietic Stem Cell TransplantationNCT06564233
Supportive Care Intervention for Outpatient Stem Cell Transplant Patients
A study testing care.coach Avatar™ in people with Hematopoietic Stem Cell Transplantation and Cancer, run by Victor Wang at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Cancer
- What is being tested?
- care.coach Avatar™
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 29 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Seen for outpatient RIC HCT (prior to D0, generally D-6).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Amar H Kelkar, MD, amarh_kelkar@dfci.harvard.edu
Gregory A Abel, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hematopoietic Stem Cell Transplantation, Cancer
- Being tested
- care.coach Avatar™
- Keywords
- health coaching, conversational relational agents
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care.coach Avatar™Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HADS-A
Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale
Measured: Baseline, Day 20 (D+20) post-transplant
Secondary outcomes (3)
FACT-BMT
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation
Measured: Baseline, Day 20 (D+20) post-transplant
HADS-A
Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale
Measured: Baseline, Day 90 (D+90) post-transplant
FACT-BMT
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation
Measured: Baseline, Day 90 (D+90) post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start21 Oct 2024
- Primary completion20 Sep 2026 (estimated)
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Victor Wang
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute, care.coach corporation
- Responsible party
- Sponsor-investigator, Victor Wang, Friendi.fi Corporation
- Investigators
- Victor Wang, MS, Principal investigator, Friendi.fi CorporationChantal M Kerssens, PhD, Study director, Friendi.fi Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564233
- Sponsor's protocol ID
- DFCI 24-183
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Avatar-based Supportive Care Intervention for Patients Undergoing Outpatient Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06564233
- Acronym / sponsor ID
- DFCI 24-183
- Conditions
- Hematopoietic Stem Cell Transplantation, Cancer
- Keywords
- health coaching, conversational relational agents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Victor WangIndustry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute, care.coach corporation
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| care.coach Avatar™ | Experimental | Behavioral: 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. |
| Usual Supportive Care | No intervention | –Traditional supportive care comprising of a binder with HCT educational materials and regular meetings with a transplant nurse. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18+
- Seen for outpatient RIC HCT (prior to D0, generally D-6).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | care.coach Avatar™ |
Primary outcome
HADS-A
Time frame: Baseline, Day 20 (D+20) post-transplant
Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale
3 secondary outcomes
FACT-BMT
Time frame: Baseline, Day 20 (D+20) post-transplant
HADS-A
Time frame: Baseline, Day 90 (D+90) post-transplant
FACT-BMT
Time frame: Baseline, Day 90 (D+90) post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Wang, MS principal investigator
Friendi.fi Corporation
Chantal M Kerssens, PhD study director
Friendi.fi Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care.coach Avatar™ in people with Hematopoietic Stem Cell Transplantation and Cancer, run by Victor Wang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantal M Kerssens, PhD (404-849-8323, chantal@friendi.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HADS-A (time frame: Baseline, Day 20 (D+20) post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.