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

NCT07049237 | Completed

• 1 other identifier: 2023S00501
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Chemotherapy; Cancer-Related Fatigue; CRF; Self-Management Ability; Quality of Life; QoL; Evidence-Based Nursing; Quantitative Assessment Strategy; Edmonton Symptom Assessment Scale

Outcome Measures

Primary Outcomes (1)

• Change in Cancer-Related Fatigue (CRF)

  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.

  Baseline, 1 month, and 3 months post-intervention.

Secondary Outcomes (3)

• Change in Self-Management Ability

  Baseline, 1 month, and 3 months post-intervention.

• Change in Quality of Life (QoL)

  Baseline, 1 month, and 3 months post-intervention.

• Incidence of Chemotherapy-Related Adverse Events

  Assessed daily during the intervention period (up to 3 months).

Study Arms (2)

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

EXPERIMENTAL

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.

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

Routine Nursing Care Group

ACTIVE COMPARATOR

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.

Behavioral: Routine Nursing Care

Interventions

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.

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

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.

Routine Nursing Care Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

CN (1)