Impact of Perioperative Acceptance-based Intervention on Early Psychological and Fanctional Recovery of Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Postoperative pain as measured by VAS score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven colorectal adenocarcinoma
- •Age > 18 years
排除标准
- •Metastasis at time of diagnosis
- •Recurrence at time of diagnosis
- •History of other malignancies
- •Mental retardation
- •Illiteracy
- •ASA score>3
- •Poor performance status
结局指标
主要结局
Postoperative pain as measured by VAS score
时间窗: 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).
次要结局
- Functional status as measured by "Maintain Function" Scale (MFS)(Third postoperative day)
- Anxiety and depression measured by Brief Illness Perception Questionnaire (Brief IPQ)(Third postoperative day)
- Anxiety and depression measured by State-Trait Anxiety (STAI) questionnaire(Third postoperative day)
研究者
George Theodoropoulos
Associate Professor of Surgery
National and Kapodistrian University of Athens