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

NCT ID: NCT07049237

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-01

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Routine Nursing Care

Intervention Type: 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.

Interventions

Evidence-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.

Intervention Type: BEHAVIORAL

Routine 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feifei Wang

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2023S00501

Identifier Type: -

Identifier Source: org_study_id