Effects of Evidence-Based Nursing Under a Quantitative Assessment Strategy on Cancer-Related Fatigue, Self-Management Ability, and Quality of Life in Lung Cancer Patients Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Cancer-Related Fatigue (CRF)
研究概览
简要总结
This prospective randomized controlled trial investigated the effects of an evidence-based nursing intervention under a quantitative assessment strategy (EB-NQAS), utilizing the Edmonton Symptom Assessment Scale (ESAS), on cancer-related fatigue, self-management ability, and quality of life in lung cancer patients undergoing chemotherapy. Outcomes were compared to a group receiving routine nursing care.
详细描述
Lung cancer patients undergoing chemotherapy frequently experience significant cancer-related fatigue (CRF) and diminished quality of life (QoL), which may not be adequately addressed by conventional nursing approaches. This study aimed to evaluate the efficacy of an evidence-based nursing intervention guided by a quantitative assessment strategy (EB-NQAS). The EB-NQAS group (n=75) received personalized care plans developed by a dedicated nursing team. These plans were based on quantitative symptom assessment using the Edmonton Symptom Assessment Scale (ESAS) and incorporated evidence-based interventions for pain management (e.g., graded approach, music therapy, opioids), fatigue (e.g., activity plans, sleep optimization), nausea/vomiting prevention (e.g., prophylactic antiemetics, ginger, dietary advice), and psychological support (e.g., cognitive-behavioral therapy). Care plans were dynamically evaluated and adjusted based on daily and weekly ESAS monitoring. The control group (n=75) received routine nursing care, including standard health education, psychological support, dietary guidance, and adverse effect management. The study compared the effects of EB-NQAS versus routine nursing on CRF, self-management ability, QoL, and adverse events over a 3-month intervention period in 150 randomized lung cancer patients.
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
- •Pathologically or radiologically confirmed lung cancer (World Health Organization [WHO] 2021 diagnostic criteria).
- •Scheduled to receive first-line chemotherapy (platinum-based regimen).
- •Karnofsky Performance Status (KPS) score ≥
- •Estimated survival time >6 months (assessed by treating oncologist).
- •Normal mental and cognitive function (Mini-Mental State Examination [MMSE] score ≥24).
- •Voluntary participation and signed informed consent.
排除标准
- •Concurrent severe organ dysfunction (Child-Pugh score ≥B for liver; estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m² for kidney).
- •Active neurological disorders (e.g., stroke, epilepsy) affecting symptom reporting.
- •Acute infectious diseases (e.g., tuberculosis with sputum positivity).
- •Known allergies to chemotherapy drugs (e.g., platinum agents).
- •Acute illnesses requiring hospitalization (e.g., pneumonia, myocardial infarction).
- •Secondary malignancies (pathologically confirmed).
- •Chemotherapy contraindications (e.g., uncontrolled heart failure).
- •Inability to communicate in the local language (assessed via nurse interview).
- •Concurrent radiotherapy or immunotherapy.
- •Participation in other interventional clinical trials within 3 months.
研究组 & 干预措施
Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS) Group
Participants (n=75) received evidence-based nursing under a quantitative assessment strategy. This involved baseline assessment with ESAS; tailored care planning for pain, fatigue, nausea/vomiting, and psychological distress (including CBT, activity/sleep plans, prophylactic antiemetics); and dynamic daily/weekly evaluation and adjustment of care based on ESAS scores.
干预措施: Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS) (Behavioral)
Routine Nursing Care Group
Participants (n=75) received standard nursing care as per hospital guidelines, including health education on lung cancer and chemotherapy, weekly 15-minute psychological support sessions, individualized dietary guidance, and verbal instructions on managing adverse effects.
干预措施: Routine Nursing Care (Behavioral)
结局指标
主要结局
Change in Cancer-Related Fatigue (CRF)
时间窗: Baseline, 1 month, and 3 months post-intervention.
Assessed using the Piper Fatigue Scale (PFS). The PFS consists of 22 items covering 4 domains (behavioral, emotional, cognitive, physical), with each item scored from 0 to 10. The total score ranges from 0 to 220, where higher scores indicate more severe fatigue.
次要结局
- Change in Quality of Life (QoL)(Baseline, 1 month, and 3 months post-intervention.)
- Change in Self-Management Ability(Baseline, 1 month, and 3 months post-intervention.)
- Incidence of Chemotherapy-Related Adverse Events(Assessed daily during the intervention period (up to 3 months).)
研究者
Feifei Wang
Principal investigator
The First Hospital of Hebei Medical University