RCT Supportive Care Outpatient RIC HCT

Trial Title: RCT Supportive Care Outpatient RIC HCT

NCT ID: NCT06564233

Condition: Hematopoietic Stem Cell Transplantation
Cancer

Conditions: Keywords:
health coaching
conversational relational agents

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: care.coach Avatar™
Description: 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.
Arm group label: care.coach Avatar™

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.

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Contact:
Last name: Amar H Kelkar, MD
Email: amarh_kelkar@dfci.harvard.edu

Investigator:
Last name: Gregory A Abel, MD
Email: Principal Investigator

Start date: September 2024

Completion date: October 2025

Lead sponsor:
Agency: care.coach corporation
Agency class: Industry

Collaborator:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Source: care.coach corporation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06564233