Clinical Study on the Impact of a Self-Efficacy Theory-Based Nursing Model on Psychological Distress, Pain Level, and Quality of Life in Lung Cancer Patients Treated With CyberKnife
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in General Self-Efficacy
研究概览
简要总结
This study evaluates whether a multi-component nursing model based on self-efficacy theory can alleviate psychological distress, mitigate pain, and improve the quality of life (QoL) in lung cancer patients undergoing CyberKnife stereotactic radiosurgery compared to routine nursing care.
详细描述
Lung cancer patients undergoing CyberKnife stereotactic radiosurgery often experience significant psychological distress, including profound fear and anxiety, as well as pain, which negatively impacts their quality of life. This single-center, prospective, randomized controlled trial investigated a structured nursing intervention based on Albert Bandura's self-efficacy theory. A total of 300 lung cancer patients scheduled for CyberKnife treatment were randomly assigned (1:1 ratio) to an intervention group or a control group. The control group received standard medical and routine nursing care. The intervention group received a multi-component nursing model in addition to routine care. The intervention included cognitive-behavioral strategies, psychological support, role model encouragement, functional exercise guidance, social support system enhancement, and self-management training, which was initiated upon admission and continued for 4 weeks. The primary hypothesis is that this theory-based approach will significantly improve general self-efficacy, reduce symptom burden (anxiety and pain), and enhance overall quality of life compared to standard care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 40 and 80 years, inclusive.
- •Histologically or cytologically confirmed diagnosis of primary lung cancer (suitable for CyberKnife treatment).
- •Scheduled to receive CyberKnife stereotactic radiosurgery as a primary or palliative treatment.
- •Karnofsky Performance Status (KPS) score of 80-
- •Patient-Generated Subjective Global Assessment (PG-SGA) score ≤
- •Estimated life expectancy of at least 6 months.
- •Able to understand, speak, and read Mandarin Chinese.
- •Willing and able to provide written informed consent.
排除标准
- •Presence of severe, uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases.
- •Known history of severe psychiatric disorders or cognitive impairment.
- •Presence of other active malignancies requiring systemic treatment.
- •Known severe, uncontrolled endocrine or metabolic diseases.
- •Significant coagulation disorders.
- •Previous radiotherapy to the planned CyberKnife treatment field.
- •Participation in another interventional clinical trial concurrently or within 30 days prior to enrollment.
研究组 & 干预措施
Self-Efficacy Nursing Group
Patients received routine nursing care plus a structured, multi-component nursing intervention based on self-efficacy theory. The core components delivered over 4 weeks included: cognitive-behavioral education (to correct misconceptions and set realistic goals), psychological support (active listening and guided relaxation), role-model encouragement (sharing experiences of successful patients), functional exercise guidance (gentle breathing and physical activity), reinforcement of social support systems, and self-management skill training (symptom monitoring and action plans).
干预措施: Self-Efficacy Theory-Based Nursing Model (Behavioral)
Control Group
Patients received standard medical care and routine nursing care. This included standard pre-treatment education regarding the CyberKnife procedure, basic symptom monitoring and management, general psychological support during routine interactions, and standard discharge planning.
干预措施: Routine Nursing Care (Behavioral)
结局指标
主要结局
Change in General Self-Efficacy
时间窗: Baseline and 4 weeks
Change in general self-efficacy was assessed using the General Self-Efficacy Scale (GSES). The GSES is a 10-item psychometric scale where each item is rated on a 4-point Likert scale. Total scores range from 10 to 40, with higher scores indicating greater perceived self-efficacy to cope with difficulties.
次要结局
- Change in Anxiety Level(Baseline and 4 weeks)
- Change in Pain Intensity(Baseline and 4 weeks)
- Change in Quality of Life (Physical Component Summary)(Baseline and 4 weeks)
- Change in Quality of Life (Mental Component Summary)(Baseline and 4 weeks)
研究者
Yusha Yan
Principal investigator
The First Hospital of Hebei Medical University