Lung Cancer
Conditions
Keywords
Chemotherapy, Cancer-Related Fatigue, CRF, Self-Management Ability, Quality of Life, QoL, Evidence-Based Nursing, Quantitative Assessment Strategy, Edmonton Symptom Assessment Scale
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEvidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS)
A multifaceted nursing program using the Edmonton Symptom Assessment Scale (ESAS) for quantitative symptom assessment to guide personalized, evidence-based care plans. Interventions included tailored strategies for pain management (graded, music therapy, heat, opioids), fatigue (supervised walking, sleep optimization), nausea/vomiting prevention (prophylactic antiemetics, ginger, dietary advice), and psychological support (cognitive-behavioral therapy). Care plans were dynamically monitored and adjusted.
BEHAVIORALRoutine Nursing Care
Standard hospital oncology nursing care including health education, general psychological support (weekly 15-minute sessions), dietary guidance based on nutritional risk screening, and verbal instructions for managing common adverse effects.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 ≥60. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cancer-Related Fatigue (CRF) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Management Ability | Baseline, 1 month, and 3 months post-intervention. | Evaluated using the Adult Health Self-Management Scale (AHSMSRS). This 38-item scale assesses 3 domains (environment, behavior, cognition), with items scored from 1 to 5. The total score ranges from 38 to 190, with higher scores indicating better self-management ability. |
| Change in Quality of Life (QoL) | Baseline, 1 month, and 3 months post-intervention. | Measured using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQ-C30). This questionnaire assesses 4 functioning domains and 5 symptom domains. Scores are normalized to a 0-100 scale; higher scores represent better functioning/QoL for functioning scales and more severe symptoms for symptom scales. |
| Incidence of Chemotherapy-Related Adverse Events | Assessed daily during the intervention period (up to 3 months). | Occurrence of chemotherapy-related adverse effects, including gastrointestinal reactions (nausea/vomiting ≥CTCAE grade 2), hepatic dysfunction (AST/ALT \>2 times Upper Limit of Normal), myelosuppression (neutrophils \<1.5×10⁹/L), neurotoxicity (peripheral numbness ≥grade 2), and alopecia. Adverse events were recorded daily using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
Countries
China
Outcome results
None listed