Clinical trial NCT06564233: RCT Supportive Care Outpatient RIC HCT
Official title: A Randomized Controlled Trial of an Avatar-based Supportive Care Intervention for Patients Undergoing Outpatient Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Cancer
Keywords: health coaching
conversational relational agents
Lead sponsor: care.coach corporation
Sponsor class: INDUSTRY
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2024-08-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: HADS-A
timeFrame: Baseline, Day 20 (D+20) post-transplant
Secondary outcomes:
measure: FACT-BMT
timeFrame: Baseline, Day 20 (D+20) post-transplant
measure: HADS-A
timeFrame: Baseline, Day 90 (D+90) post-transplant
measure: FACT-BMT
timeFrame: Baseline, Day 90 (D+90) post-transplant
Other outcomes:
measure: Conversions
timeFrame: Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant
measure: HADS-D
timeFrame: Baseline, Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: care.coach corporation
name: Victor Wang, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: care.coach corporation
name: Chantal M Kerssens, PhD
role: STUDY_DIRECTOR
References: