Supportive Care Intervention for Outpatient Stem Cell Transplant Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorVictor Wang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18+
Seen for outpatient RIC HCT (prior to D0, generally D-6).
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
care.coach Avatar™
Behavioralcare.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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: care.coach Avatar™Experimental treatment 1 intervention
Group B: Usual Supportive CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
HADS-A
Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale
Time frame
Baseline, Day 20 (D+20) post-transplantSecondary outcomes
1
FACT-BMT
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation
Time frame
Baseline, Day 20 (D+20) post-transplant2
HADS-A
Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale
Time frame
Baseline, Day 90 (D+90) post-transplant3
FACT-BMT
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation
Time frame
Baseline, Day 90 (D+90) post-transplantOther outcomes
1
Conversions
Conversion from Outpatient to Inpatient Transplant
Time frame
Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant2
HADS-D
Hospital Anxiety and Depression Scale (HADS) - Depression subscale
Time frame
Baseline, Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Victor Wang
Lead sponsor
Friendi.fi Corporation
Sponsor institution
Dana-Farber Cancer Institute
Collaborator
care.coach corporation
Collaborator
Source ClinicalTrials.gov