Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative decision regrets
研究概览
简要总结
Patients undergoing major abdominal surgery often have to make complex decisions about their treatment, where risks, benefits and possible complications must be considered. Limited health literacy and unmet expectations can make this process difficult and may increase the risk of regret after surgery, as well as feelings of not having received sufficient support or clear information.
The aim of this study is to explore how well patients understand the information they receive before surgery, what expectations they have and how these expectations relate to their postoperative experiences. The study includes patients undergoing major abdominal cancer surgery, such as pancreatic, liver, esophageal, gastric, or large bowel surgery, at Copenhagen University Hospital, Rigshospitalet. Data will be collected before surgery, one month after discharge and again three months later.
详细描述
Patients undergoing major abdominal cancer surgery often face complex treatment decisions that involve weighing potential benefits against significant risks, including postoperative complications and prolonged recovery. In such situations, adequate patient information, realistic expectations and sufficient health literacy may be essential for supporting informed decision-making. When patients feel insufficiently informed or experience a mismatch between their expectations and postoperative outcomes, this may contribute to decision regret and reduced quality of life.
The purpose of this study is to explore the relationship between health literacy, preoperative information, patient expectations, and postoperative experiences in patients undergoing major abdominal cancer surgery. In particular, the study will examine how these factors relate to postoperative decision regret and health-related quality of life.
This is a prospective observational cohort study conducted at the Department of Transplantation and Digestive Diseases at Copenhagen University Hospital, Rigshospitalet, Denmark. Patients undergoing major abdominal cancer surgery, including pancreatic, hepatic, esophageal, gastric, and major colorectal procedures, will be invited to participate.
Data will be collected at baseline before surgery and at follow-up approximately one month and three months after surgery. Participants will complete validated questionnaires about health literacy, treatment expectations, perceived information received before surgery, anxiety and depression, decision regret and health-related quality of life. In addition, a subgroup of participants will be invited to participate in semi-structured qualitative interviews to explore how their preoperative expectations correspond with their postoperative experiences.
The study aims to improve understanding of how patient-related factors such as health literacy and expectations influence postoperative experiences and decision regret. The findings may contribute to a better understanding of factors associated with postoperative decision regret and patient-reported outcomes following major abdominal cancer surgery.
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 undergoing elective surgical treatment.
- •Patients who can read and understand the Danish language.
排除标准
- •- Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator.
- •In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason
研究组 & 干预措施
Surgery, major pancreatic
Whipples resection, total pancreatectomy or distal pancreatectomy
Surgery, major hepatic
Hilar cholangiocarcinoma, major liver resection (3 segments or more)
Large bowel/sarcoma resections
Surgery, major esophageal or stomach
Ivor Lewis esophagectomy, total or subtotal gastrectomy
结局指标
主要结局
Postoperative decision regrets
时间窗: 1 month, and 3 months
Decision regret will be measured using the Danish version of the Decision Regret Scale (DRS). The scale consists of 5 items assessing the degree of regret following the surgical decision. Each item is rated on a 5-point scale, and the total score is transformed to a 0-100 scale, where 0 indicates no regret and 100 indicates high regret.
次要结局
- Preoperative anxiety and depression(Baseline)
- Quality of information(Perioperative)
- Patients' preoperative expectations(Baseline)
- Health literacy(Baseline)
- Fulfillment of patient expectations(1 month)
- Health-related quality of life(Baseline, 1 month, and 3 months)
研究者
Anja Edith Geisler
Nursing Research Manager, Senior Preacher/Associate Professor, Dr. med
Rigshospitalet, Denmark