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临床试验/NCT02697357
NCT02697357已完成不适用

Emotion Regulation Therapy to Address Distress Among Caregivers

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年10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
32
试验地点
1
主要终点
number of patients completing at least 6 out of the 8-sessions

研究概览

简要总结

The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include partners, family members, children, parents, and friends providing informal care to a patient. Providing care to someone with cancer can be difficult. The purpose of this intervention is to improve coping and physical well-being among caregivers, which in turn will allow them to provide better care for their loved ones. Investigators would also like to learn about biological factors like stress that may affect one's emotional and physical well-being. This study will allow to better understand caregivers needs, and further develop a program to provide services to caregivers within MSKCC community and nationwide.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • As per self-report, age 18 or over
  • As per self-report, a current caregiver to a patient with any site or stage of cancer
  • score of ≥ 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role. Potential participants will be asked whether or not their distress is in any way related to their caregiving experience. Individuals who answer "no" will be asked whether or not their distress started or has gotten worse since the patient began treatment or was diagnosed.
  • Either a score of ≥ 15 on the Brief Penn State Worry Questionnaire OR a score > 12 on the Brooding Subscale of the Rumination Response Scale
  • In the judgment of the investigators and/or consenting professional, able to read and comprehend English
  • In the judgment of the consenting professional cognitively able to provide informed consent

排除标准

  • As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
  • In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
  • If participating in optional biospecimen collection;as per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease)
  • As per self-report, is a regular smoker (daily use)
  • As per self-report, is a heavy drinker (regularly having more than 14 alcoholic beverages per week for men, 7 for women)
  • As per self- report, engaging in night shift work
  • As per self- report, currently engaged in ongoing psychotherapy.

结局指标

主要结局

number of patients completing at least 6 out of the 8-sessions

时间窗: 1 year

feedback from participants by qualitative research methods

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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