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临床试验/NCT07049250
NCT07049250已完成不适用

Effect of Evidence-Based Nursing Intervention Under Quantitative Evaluation Strategy on Psychological Resilience and Illness Perception in Lung Cancer Patients Undergoing Chemotherapy

The First Hospital of Hebei Medical University1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
1
主要终点
Change in Psychological Resilience Score

研究概览

简要总结

This study investigates the effect of an evidence-based nursing intervention, guided by a quantitative evaluation strategy, on psychological resilience and illness perception in lung cancer patients undergoing chemotherapy. Patients were randomized to receive either the specialized nursing intervention or routine nursing care, with outcomes assessed at baseline and 3 months post-intervention.

详细描述

Lung cancer patients undergoing chemotherapy often experience significant physical and psychological distress. Conventional nursing may not adequately address these multifaceted needs. Evidence-based nursing (EBN) integrates research evidence, clinical expertise, and patient preferences. This study evaluated an EBN intervention model guided by a quantitative evaluation strategy, which involves multidisciplinary risk assessment, tailored interventions including psychological support, cognitive restructuring, and complication prevention. The study aimed to determine if this model could improve psychological resilience, illness perception, coping styles, and reduce chemotherapy-related complications in lung cancer patients compared to routine nursing care. A total of 142 patients were randomized. The intervention group received a comprehensive EBN program including risk stratification, psychological/cognitive interventions (e.g., cognitive-behavioral techniques, peer mentoring, family counseling), systematic complication prevention (e.g., prophylactic antiemetics, dietary guidance, infection control), and sleep optimization. The control group received standard disease education, exercise guidance, and medication adherence counseling. Outcomes were measured at baseline and 3 months post-intervention.

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

性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of lung cancer confirmed according to the Chinese Quality Control Indicators for Standardized Diagnosis and Treatment of Primary Lung Cancer (2022) through both imaging and histopathological examination.
  • •TNM staging determined using the 8th edition AJCC/UICC classification system.
  • •Scheduled to receive chemotherapy with an expected survival exceeding one year.
  • •Demonstrated normal cognitive and communication abilities as assessed by standardized neuropsychological tests.
  • •Provided written informed consent prior to enrollment.

排除标准

  • •Pre-existing neurological disorders.
  • •Significant organ dysfunction (defined as Child-Pugh class B/C for liver function or eGFR <30 mL/min/1.73m² for renal function).
  • •Active infectious diseases.
  • •Contraindications to chemotherapy.
  • •Concurrent radiotherapy.

研究组 & 干预措施

Evidence-Based Nursing Intervention Group

Experimental

Participants (n=71) received evidence-based nursing intervention guided by quantitative evaluation strategy. This included: 1) comprehensive risk assessments by a multidisciplinary team; 2) dynamic risk stratification for care intensity; 3) psychological and cognitive interventions (cognitive-behavioral techniques, peer mentoring, family counseling); 4) systematic complication prevention strategies (prophylactic antiemetics, dietary guidance, infection control); 5) sleep optimization protocols.

干预措施: Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy (Behavioral)

Routine Nursing Care Group

Active Comparator

Participants (n=71) received routine nursing care. This consisted of standard disease education covering chemotherapy side effects and self-management strategies, personalized exercise guidance focusing on maintaining physical function, and medication adherence counseling, delivered in 30-minute sessions twice weekly for a duration of two months.

干预措施: Routine Nursing Care (Behavioral)

结局指标

主要结局

Change in Psychological Resilience Score

时间窗: Baseline and 3 months post-intervention.

Psychological resilience assessed using the 25-item Resilience Scale. Scores range from 0 to 100, with higher scores indicating better psychological resilience. The scale measures optimism, resilience, and strength subdomains.

次要结局

  • Change in Illness Perception(Baseline and 3 months post-intervention.)
  • Change in Coping Styles(Baseline and 3 months post-intervention.)
  • Incidence of Chemotherapy-Related Complications(Assessed throughout the 3-month post-intervention period.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feifei Wang

Principal investigator

The First Hospital of Hebei Medical University

研究点 (1)

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