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临床试验/NCT06564233
NCT06564233招募中不适用

A Randomized Controlled Trial of an Avatar-based Supportive Care Intervention for Patients Undergoing Outpatient Stem Cell Transplantation

Victor Wang1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Victor Wang
入组人数
90
试验地点
1
主要终点
HADS-A

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Seen for outpatient RIC HCT (prior to D0, generally D-6).

排除标准

  • 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.

研究组 & 干预措施

care.coach Avatar™

Experimental

care.coach Avatar™ with usual supportive care. The avatar program includes companionship, HCT educational modules, relaxation and mindfulness exercises, simple (seated) physical exercises, nightly check ins, and symptom self-management as needed.

干预措施: care.coach Avatar™ (Behavioral)

Usual Supportive Care

No Intervention

Traditional supportive care comprising of a binder with HCT educational materials and regular meetings with a transplant nurse.

结局指标

主要结局

HADS-A

时间窗: Baseline, Day 20 (D+20) post-transplant

Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale

次要结局

  • HADS-A(Baseline, Day 90 (D+90) post-transplant)
  • FACT-BMT(Baseline, Day 90 (D+90) post-transplant)
  • FACT-BMT(Baseline, Day 20 (D+20) post-transplant)

研究者

发起方
Victor Wang
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Victor Wang

Co-founder, President

Friendi.fi Corporation

研究点 (1)

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