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Evidence-Based Nursing for Fatigue and Quality of Life in Lung Cancer Chemotherapy

H

Hebei Medical University

Status

Completed

Conditions

Lung Cancer

Treatments

Behavioral: Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS)
Behavioral: Routine Nursing Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07049237
2023S00501

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS) Group
Experimental group
Description:
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.
Treatment:
Behavioral: Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS)
Routine Nursing Care Group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Routine Nursing Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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