跳至主要内容
临床试验/NCT01061801
NCT01061801已完成不适用

Emotional Expression and Cancer Caregivers

Fred Hutchinson Cancer Center2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2006年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
2
主要终点
Self-reported mental and physical health as measured by the Short Form-36 Health Survey

研究概览

简要总结

This study seeks to test a brief psychological intervention for spousal caregivers of cancer patients (specifically, hematopoietic stem cell transplant patients), persons known to experience emotional distress.

详细描述

This project focuses on spousal caregivers (CGs) of hematopoietic stem cell transplant survivors - persons known to report elevated levels of distress as compared to both norms and their patient counterparts. Specific Aims are to: (1) Determine, via experimental manipulation, whether or not CGs of hematopoietic stem cell transplant patients engage in protective buffering, a coping mechanism whereby partners shield patients from illness-related concerns or worries, (2) Examine synchrony or lack thereof, desynchrony, among subjective, expressive and biologic indicators of emotion among spousal CGs, and (3) Test the feasibility and implementation of an emotional expression (EE) exercise designed to enhance psychological and immune functioning among spousal CGs.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • patients and partners at least 21 years of age
  • patients and partners English speaking
  • patients about to receive a hematopoietic stem cell transplant
  • patients married or in a committed, cohabiting, heterosexual or homosexual relationship
  • caregivers in a married or committed, cohabiting, heterosexual or homosexual relationship with the patient
  • caregivers present at the transplant site and planning to remain so for at least one month

排除标准

  • patient major psychiatric disorder
  • caregiver presence or history of a neurologic disorder

结局指标

主要结局

Self-reported mental and physical health as measured by the Short Form-36 Health Survey

时间窗: baseline, 1-month follow-up, and 4-month follow-up

Marital satisfaction as measured by the Dyadic Adjustment Scale

时间窗: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up

Self- and partner-reported protective buffering as measured by the Protective Buffering Scale

时间窗: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up

次要结局

  • Galvanic skin response (physiological indicator of emotion)(During intervention/ disclosure sessions)
  • Emotional experience as assessed by the Positive and Negative Affect Schedule(During intervention/ disclosure sessions)
  • Emotional expression (facial expression and words uttered)(During intervention/ disclosure sessions)

研究者

申办方类型
Other

研究点 (2)

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