Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Correlation between psychological predictors questionnaires outcome and length of hospital stay
研究概览
简要总结
This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal cancer surgery.
详细描述
Preliminary evidence suggests that there are multiple variables that may influence the functional recovery following colorectal cancer surgery, some of which deal with the psychological domain. Distress and depression can negatively affect the perceptions of functional ability, while resilience and effective coping styles promote a better psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation and interventions have been proposed as a feasible and cost-effective way to positively influence the recovery after surgery in association with the Enhanced Recovery After Surgery (ERAS) protocol.
In particular, mindfulness is proved to be associated with higher quality of life in different medical conditions, including oncological patients and has been also associated with improved clinical outcomes.
The aim of the study is to investigate the association of mindfulness and other psychological predictors with functional and quality of life outcomes in patients undergoing colorectal surgery for oncological condition.
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
- 否
入选标准
- •Patients > 18 years old (both males and females).
- •Patients diagnosed with colorectal cancer.
- •Patients scheduled for elective open or laparoscopic surgery for curative intent.
排除标准
- •Patients unable to give the written informed consent.
- •Patients < 18 years old.
- •Patients undergoing surgery in emergency setting.
- •Patients with pre-operative evidence of metastatic cancer or colorectal cancer recurrence.
- •Pregnant or breastfeeding patients.
- •Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia).
结局指标
主要结局
Correlation between psychological predictors questionnaires outcome and length of hospital stay
时间窗: Post-operative day 7
Length of stay calculated in days from the day of surgery until the day of discharge
Correlation between psychological predictors questionnaires outcome and quality of life
时间窗: Post-operative month 12
Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)
次要结局
未报告次要终点