Evidence-Based Nursing for Psychological Resilience in Lung Cancer Chemotherapy Patients

NCT ID: NCT07049250

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-01

Brief Summary

This study investigates the effect of an evidence-based nursing intervention, guided by a quantitative evaluation strategy, on psychological resilience and illness perception in lung cancer patients undergoing chemotherapy. Patients were randomized to receive either the specialized nursing intervention or routine nursing care, with outcomes assessed at baseline and 3 months post-intervention.

Detailed Description

Lung cancer patients undergoing chemotherapy often experience significant physical and psychological distress. Conventional nursing may not adequately address these multifaceted needs. Evidence-based nursing (EBN) integrates research evidence, clinical expertise, and patient preferences. This study evaluated an EBN intervention model guided by a quantitative evaluation strategy, which involves multidisciplinary risk assessment, tailored interventions including psychological support, cognitive restructuring, and complication prevention. The study aimed to determine if this model could improve psychological resilience, illness perception, coping styles, and reduce chemotherapy-related complications in lung cancer patients compared to routine nursing care. A total of 142 patients were randomized. The intervention group received a comprehensive EBN program including risk stratification, psychological/cognitive interventions (e.g., cognitive-behavioral techniques, peer mentoring, family counseling), systematic complication prevention (e.g., prophylactic antiemetics, dietary guidance, infection control), and sleep optimization. The control group received standard disease education, exercise guidance, and medication adherence counseling. Outcomes were measured at baseline and 3 months post-intervention.

Conditions

Lung Cancer

Study Design

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

Study Groups

Evidence-Based Nursing Intervention Group

Participants (n=71) received evidence-based nursing intervention guided by quantitative evaluation strategy. This included: 1) comprehensive risk assessments by a multidisciplinary team; 2) dynamic risk stratification for care intensity; 3) psychological and cognitive interventions (cognitive-behavioral techniques, peer mentoring, family counseling); 4) systematic complication prevention strategies (prophylactic antiemetics, dietary guidance, infection control); 5) sleep optimization protocols.

Group Type: EXPERIMENTAL

Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy

Intervention Type: BEHAVIORAL

A multifaceted nursing program incorporating comprehensive risk assessment, dynamic risk stratification, psychological and cognitive interventions (including cognitive-behavioral techniques, peer mentoring, family counseling), systematic complication prevention strategies (including prophylactic antiemetics, dietary guidance, infection control), and sleep optimization protocols.

Routine Nursing Care Group

Participants (n=71) received routine nursing care. This consisted of standard disease education covering chemotherapy side effects and self-management strategies, personalized exercise guidance focusing on maintaining physical function, and medication adherence counseling, delivered in 30-minute sessions twice weekly for a duration of two months.

Group Type: ACTIVE_COMPARATOR

Routine Nursing Care

Intervention Type: BEHAVIORAL

Standard disease education on chemotherapy side effects and self-management, personalized exercise guidance, and medication adherence counseling. Delivered in 30-minute sessions twice weekly for two months.

Interventions

Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy

A multifaceted nursing program incorporating comprehensive risk assessment, dynamic risk stratification, psychological and cognitive interventions (including cognitive-behavioral techniques, peer mentoring, family counseling), systematic complication prevention strategies (including prophylactic antiemetics, dietary guidance, infection control), and sleep optimization protocols.

Intervention Type: BEHAVIORAL

Routine Nursing Care

Standard disease education on chemotherapy side effects and self-management, personalized exercise guidance, and medication adherence counseling. Delivered in 30-minute sessions twice weekly for two months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of lung cancer confirmed according to the Chinese Quality Control Indicators for Standardized Diagnosis and Treatment of Primary Lung Cancer (2022) through both imaging and histopathological examination.
• TNM staging determined using the 8th edition AJCC/UICC classification system.
• Scheduled to receive chemotherapy with an expected survival exceeding one year.
• Demonstrated normal cognitive and communication abilities as assessed by standardized neuropsychological tests.
• Provided written informed consent prior to enrollment.

Exclusion Criteria

• Pre-existing neurological disorders.
• Significant organ dysfunction (defined as Child-Pugh class B/C for liver function or eGFR <30 mL/min/1.73m² for renal function).
• Active infectious diseases.
• Contraindications to chemotherapy.
• Concurrent radiotherapy.

• 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

2024S00040

Identifier Type: -

Identifier Source: org_study_id