跳至主要内容
临床试验/NCT03210727
NCT03210727已完成不适用

A Mixed Methods Descriptive Study Exploring the Needs and Preferences of Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Enrollment statistics

研究概览

简要总结

The investigators will use a single arm design and deliver a new supportive intervention entitled, "Ready to Connect, Actively Relax and Exercise (CARE)." The purpose of the study is to describe the feasibility, acceptability, and potential effectiveness of the Ready to CARE intervention. Effectiveness outcomes include caregiver self-efficacy, distress, and coping style, and patient quality of life, symptom burden, and healthcare utilization.

详细描述

During the first phase of this study, the investigators enrolled caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT) into a descriptive study. The investigators used quantitative and qualitative measures to describe the caregivers self-efficacy, distress, and coping style, and solicit their opinions about how to improve our supportive care for caregivers.

Informed by those data, the investigators now will study the effectiveness of the supportive intervention.

The long-term goal of this research is to develop a pragmatic, replicable intervention that supports caregivers and promotes the health and well-being of the caregiver-HSCT patient dyad.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Providing informal, unpaid care for a person who is 18 years of age or older and is scheduled to receive an allogeneic or autologous HSCT within the next three months.
  • The caregiver's loved one ("patient") undergoing the transplant will be asked to enroll in the study to provide data regarding quality of life and symptom burden and to allow access of the medical record to ascertain healthcare utilization data. (Caregivers will not be excluded from the study if the patient declines to enroll.)

排除标准

  • Under the age of 18 for either caregiver or patient.

研究组 & 干预措施

single arm

Other

This arm will be used to pilot test the Ready to CARE program (with the caregivers) and measure outcomes (in the patients).

干预措施: Ready to CARE program (Behavioral)

结局指标

主要结局

Enrollment statistics

时间窗: Throughout the study, an average of one year

Number enrolled in study divided by number eligible

次要结局

  • Retention(Throughout the study, an average of one year)
  • Goal Attainment(Day 30 after stem cell reinfusion)
  • Session Completion(Day 30 after stem cell reinfusion)
  • Caregiver Satisfaction(Day 30 after stem cell reinfusion)
  • Caregiver Self-efficacy(Day 100 after stem cell reinfusion)
  • Caregiver Coping style(Day 100 after stem cell reinfusion)
  • Patient Quality of Life(Day 100 after stem cell reinfusion)
  • Patient symptom burden(Day 100 after stem cell reinfusion)
  • Patient healthcare utilization(Day 100 after stem cell reinfusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Lyons

Principal Investigator

Dartmouth-Hitchcock Medical Center

研究点 (2)

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CAREgiver Study for Patients Undergoing HSCT | 临床试验