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NCT Number: NCT07049237

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evidence-Based Nursing Under Quantitative Assessment Strategy (EB-NQAS)

Behavioral

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.

Routine Nursing Care

Behavioral

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.

Primary outcomes

  1. Change in Cancer-Related Fatigue (CRF)

    Time frame: 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 outcomes

  1. Change in Self-Management Ability

    Time frame: 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.

  2. Change in Quality of Life (QoL)

    Time frame: 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.

  3. Incidence of Chemotherapy-Related Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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