Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564233
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
RCT Supportive Care Outpatient RIC HCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of an Avatar-based Supportive Care Intervention for Patients Undergoing Outpatient Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this study is to assess the efficacy of the carecoach Avatar in improving anxiety and quality of life for patients undergoing outpatient transplant After carecoach 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 258 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 Prochaskas 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None