Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT06564233
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.
Study:
NCT06564233
Study Brief:
Protocol Section:
NCT06564233