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Acceptance-based Intervention at Colorectal Cancer Patients (ABICOL)

2020年10月1日 更新者：George Theodoropoulos、National and Kapodistrian University of Athens

Impact of Perioperative Acceptance-based Intervention on Early Psychological and Fanctional Recovery of Colorectal Cancer Patients

Taking into account the unavoidable effect of a major oncologic surgery commonly required for colorectal cancer patients and the recognized psychological and functional sequelae of the surgical treatment on their status, we will evaluate the influence of a psychological intervention, known as acceptance-based intervention, offered to those patients at the preoperative setting. Reduction of anxiety and assessmemt of indices of post-intervention psychological and functional recovery will be the primary goals of the study.

研究概览

地位

未知

条件

干预/治疗

详细说明

Introduction: Uncertainty, fears and anxiety are common reactions to an upcoming colectomy for colorectal cancer patients and are related not only to cancer disease, but also to the inevitable change in colon anatomy, affecting their preoperative psychological and functional condition and their postsurgical recovery.

Purpose: We aim to evaluate the psychological and functional recovery of colorectal cancer patients, who undergo colectomy, after an acceptance-based nursing intervention. The scope of this brief preoperative intervention is to enable patients to cope more efficiently with the upcoming surgery and their health status, as it is expected to reduce anxiety and have positive effect on postsurgical psychological and functional recovery.

Methods: The study includes histologically diagnosed patients with colorectal cancer, regardless of stage, who are scheduled to undergo colectomy. Patients will be divided into two groups-the experimental and the control group-by simple randomization. Both groups are going to complete a set of same questionnaires regarding quality of life, sleep, anxiety, depression and functional status. Patients in the control arm will then receive treatment-as-usual while patients in the experimental arm will also receive an acceptance-based intervention before surgery. Postoperatively, for both groups, apart from the self-reported symptoms, we will assess objective recovery factors, such as postoperative complications

研究类型

介入性

注册 (预期的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 希腊
      • Athens、希腊、11528
        • 招聘中
        • NKUAthens
        • 接触：

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

18年 及以上 (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:

  • Patients with histologically proven colorectal adenocarcinoma
  • Age > 18 years

Exclusion Criteria:

  • Metastasis at time of diagnosis
  • Recurrence at time of diagnosis
  • History of other malignancies
  • Mental retardation
  • Deafness
  • Illiteracy
  • ASA score>3
  • Poor performance status

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：随机化
  • 介入模型：并行分配
  • 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：ABICOL
24 hours prior to surgery the patients undergo acceptance-based intervention, incorporating questions about their subjective perception about the surgery, the domains of their lives that have been affected, and on their own expectations from surgery and its effects on their lives. They will be asked to express their fears and worries about their condition and they will be discussed about the likelihood of experiencing postoperative pain.
行为的：ACCEPTANCE-BASED INTERVENTION
24 hours prior to surgery the patients undergo acceptance-based intervention, incorporating questions about their subjective perception about the surgery, the domains of their lives that have been affected, and on their own expectations from surgery and its effects on their lives. They will be asked to express their fears and worries about their condition and they will be discussed about the likelihood of experiencing postoperative pain.
无干预：CONTROL
No acceptance-based intervention or other discussion related to the patients' fears and worries will be applied.

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
Postoperative pain as measured by VAS score
大体时间：Third postoperative day
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best).
Third postoperative day

次要结果测量

结果测量
措施说明
大体时间
Functional status as measured by "Maintain Function" Scale (MFS)
大体时间：Third postoperative day
"Maintain function" scale is a validated 5-item summative. Each item begins with the stem, "How confidant are you that you know or can," and assesses an aspect of daily life-function, such as work and social activities. The responses are a 5-level Likert scale from 0 = "not at all confident" to 4 = "completely confident." We did not include a "not applicable" response option. The self-efficacy scores range between 0 and 20, with a higher score indicating better self-efficacy to maintain function.
Third postoperative day
Anxiety and depression measured by Brief Illness Perception Questionnaire (Brief IPQ)
大体时间：Third postoperative day
The Brief Illness Perception Questionnaire (Brief IPQ) is a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. The Brief IPQ uses a single-item scale approach to assess perception on a 0-10 response scale. The Brief IBQ comprises 5 items on cognitive representation of illness perception: consequences, timeline, personal control, treatment control, and identity. There are 2 items on emotional representation: concern and emotions. One item is on illness comprehensibility. The last item is on perceived cause of illness, in which respondents list the three most important causal factors in their illness.
Third postoperative day
Anxiety and depression measured by State-Trait Anxiety (STAI) questionnaire
大体时间：Third postoperative day
The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
Third postoperative day

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。

赞助

National and Kapodistrian University of Athens

调查人员

  • 首席研究员：George E Theodoropoulos、Associate Professor of Surgery

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 (实际的)

2020年6月22日

初级完成 (预期的)

2021年6月22日

研究完成 (预期的)

2022年1月20日

研究注册日期

首次提交

2020年9月16日

首先提交符合 QC 标准的

2020年10月1日

首次发布 (实际的)

2020年10月5日

研究记录更新

最后更新发布 (实际的)

2020年10月5日

上次提交的符合 QC 标准的更新

2020年10月1日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IRB6/26-2-2019

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Sharing clinical trial data with other professional organizations and researchers will be important element to support best practice principles in our clinical trial.

IPD 共享时间框架

At completion of study and analysis of results

IPD 共享访问标准

If requested for universal prospective registration If requested by journals for publication If requested by researchers running similar clinical trials

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

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

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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医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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