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临床试验/NCT02948413
NCT02948413已完成不适用

Exploring the Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Traumatic Stress Symptoms

研究概览

简要总结

Background:

A cancer diagnosis is a threat to life and bodily integrity. This can cause people with cancer to experience traumatic stress. Researchers want to better understand the types of stress and emotional reactions people with cancer experience. They also want to know if the stress people with cancer have had during their life affects their stress related to cancer.

Objective:

To see if lifetime traumas, along with psychosocial distress, can predict traumatic stress symptoms in people with cancer.

Eligibility:

People ages 18 and older who have had or are currently getting care from the NIH Clinical Center for one of these cancers:

Leukemia

Lymphoma

Mesothelioma

Prostate cancer

Design:

Participants will be screened with name, date of birth, and diagnosis.

Participants will allow access to their medical records.

Participants will complete, online or in person, a demographic sheet and 3 questionnaires:

The PTSD Checklist for DSM-5: This assesses traumatic stress symptoms and takes 5 10

minutes to complete.

The Life Events Checklist for DSM-5: This assesses potentially traumatic life events and

takes about 5 minutes to complete.

The Brief Symptoms Inventory 18: This assesses psychosocial distress and takes about 4

minutes to complete....

详细描述

Background:

  • The American College of Surgeons requires accredited cancer hospitals to screen for distress.
  • Providers at the NIH CC do not uniformly screen for traumatic stress in oncology patients but have observed innumerable patients with deficits in social functioning, difficulty adhering to treatment, and trouble coping due to oncology related traumatic stress.
  • A seminal distress study reported the prevalence of distress for 14 cancer diagnoses was as high as 43.4% with prevalence of distress in the 30% range for the diagnoses covered in this study.
  • It has been shown that a cancer diagnosis represents a threat to life and bodily integrity and can create a sense of loss of social and occupational roles, causing one s adaptive capacity to become overwhelmed.
  • In oncology patients, the literature reports that symptoms or traumatic stress range from 20% with early stage cancer to 80% in those with recurrent disease.
  • The outcome of this study will provide information about traumatic stress, aid in the identification of it, and provide guidance on trauma informed care for this population.

Objectives:

  • A descriptive study to explore the relationships between levels of psychosocial distress and levels of traumatic stress symptoms (TSS) in patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.
  • We will also describe the relationship between psychosocial distress and TSS in the context of the number of lifetime traumas experienced by patients enrolled on a clinical trial at the NIH for cancer treatment.

Eligibility:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Traumatic Stress Symptoms

时间窗: Single Time Point

A descriptive study to explore the relationships between levels of psychosocial distress and levels of traumatic stress symptoms (TSS) in patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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