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Psychological Counselling in Diagnostic Screening

2013年12月20日 更新者:Malihe Shams、Istituto Oncologico Veneto IRCCS

Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study

Diagnostic tests have a deep emotional impact on oncology patients. Anxiety and worries can lead people to avoid screening tests, with high risks for health. A single arm, pilot study was organized to evaluate the feasibility and efficacy of psychological counselling for cancer patients who demonstrated anxiety for diagnostic tests. The hypothesis was that taking part in Psychoeducative Training could offer a new modality to reduce anxiety, before and during tests, and also the possibility to reinforce coping strategies.

研究概览

地位

完全的

条件

详细说明

The Psychoeducative Training was organized in 6 weekly meetings lasting two hours. Each group was composed of 6 participants. The Training follows the cognitive-behavioural model. In the first part of every meeting, theoretical aspects about stress and anxiety were explained, while in the second part some relaxation techniques were taught. During relaxation, we used a selected music that was also going to be used during the diagnostic tests. Since the first meeting, patients experienced these relaxing techniques in order to learn them. In order to support the adaptability, at the end of every meeting the participants received some homework. They had to take notes on how many times they repeated the relaxation exercises and on the anxiety level before and after the training.

For the study, 43 people were recruited. Anxiety was measured with Beck Anxiety Inventory (BAI); it values the seriousness of the physiological behaviour connected with anxiety. This test an "anxiety gauge", which allows us to obtain numerical data on emotional changes. The test is composed of 4 interpretative levels: serious, moderate, small and minimal anxiety.

The coping style was measured with Coping Orientation to Problems Experienced-New Italian Version (COPE-NIV); this test evaluates the way in which people resolve and face traumatic or usual stressful situations.

The research project was approved by the Ethics Committee of Veneto Institute of Oncology.

Every patient signed a written informed consent to process the data for research purposes and to publish it.

Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study. The average age was 52.4 and 61.5% were married.

研究类型

介入性

注册 (实际的)

43

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • age: 25 to 65 years cancer patients who must undergo diagnostic tests: TAC, PET, fMRI, Mammography, Endoscopy and Colonoscopy.
  • an anxiety level greater than 5 (in a scale from 0=very calm to 10=very anxious; using a self-reporting instrument created ad hoc)
  • signed informed consent

Exclusion Criteria:

  • healthy people

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Pilot group
Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study. Most of the 43 patients had to undergo only one diagnostic test, and only 6 patients had more than one. They have attended a psychoeducative training.
The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
其他名称:
  • Systematic Desensitization
  • Psychological counseling

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of patients considered drop-outs
大体时间:6 weeks after recruitment (end of treatment)
The proportion of patients considered drop-outs. A patient is considered a drop-out if he/she does not attend at least 2 out of 6 programmed meetings. This is a feasibility outcome
6 weeks after recruitment (end of treatment)

次要结果测量

结果测量
措施说明
大体时间
median BAI score after intervention
大体时间:6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
median COPE score - Social support score after intervention
大体时间:6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
median COPE score - Avoidance strategies score after intervention
大体时间:6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
median COPE score - Positive attitude score after intervention
大体时间:6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
median COPE score - Problem acceptance score after intervention
大体时间:6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
recruitment time (process)
大体时间:6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
mean number of recruited patients per week (process)
大体时间:6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
refusal rate among eligible patients (process)
大体时间:6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
rate of patients who obviously meet and do not meet the eligibility requirements (process)
大体时间:6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
number of questionnaires correctly filled out (process)
大体时间:6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
phone lines overloaded or waiting room overcrowded by study participants (management)
大体时间:6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Malihe Shams、Istituto Oncologico Veneto IRCCS

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年4月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年5月1日

研究注册日期

首次提交

2013年12月17日

首先提交符合 QC 标准的

2013年12月20日

首次发布 (估计)

2013年12月23日

研究记录更新

最后更新发布 (估计)

2013年12月23日

上次提交的符合 QC 标准的更新

2013年12月20日

最后验证

2013年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • IOV-2012 ANXIETY

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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