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NCT Number: NCT07679165

The Impact of Symptom Management Nursing Intervention on the QoL of Patients With Advanced Lung Cancer: Mediation of Self-management Efficacy and Regulation of Psychological Resilience

Symptom management nursing intervention can improve the self-management efficacy, psychological resilience, and QoL of patients with advanced lung cancer.

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Key information

Conditions

Symptom Managemen Late Stage Lung Cancer Mediating Effect Psychological Resilience QoL Self Management Efficacy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dahua Hospital, Xuhui District, Shanghai

Shanghai, Shanghai Municipality, 200031, China

About this study

Self management efficacy is an important mediating variable in the impact of Symptom management nursing intervention on patients' quality of life. Psychological resilience plays a negative moderating role in the effect of Symptom management nursing intervention. Late stage lung cancer patients with low psychological resilience can obtain more significant self management efficacy and quality of life improvement from Symptom management nursing intervention, and are the key beneficiaries of the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • According to the diagnostic criteria of primary lung cancer [9], the clinical stage was stage ⅢB-Ⅳ
  • aged 18-75 years old
  • Karnofsky performance status (KPS) ≥60 and expected survival ≥3 months
  • Patients had clear consciousness and normal cognitive function, and could complete the questionnaire independently or with the assistance of the researcher
  • have basic communication skills and can cooperate to complete the whole intervention
  • Patients or their families informed and signed the consent form.

Exclusion criteria

  • primary malignant tumors in other parts
  • history of severe heart, liver, kidney and other important organ failure, severe infection or mental illness
  • Unable to cooperate with the study due to cognitive impairment, visual and hearing impairment
  • participating in other similar nursing intervention studies.

Treatment and study plan

routine nursing group

Other

Patients in the routine group were given routine care, including disease monitoring, medication care, diet and nutrition guidance, basic life care, routine health education on admission and discharge, symptomatic treatment of patients' discomfort symptoms, telephone follow-up twice a week to understand the patient's condition, and no systematic and personalized SM nursing intervention.

standardized systematic SM nursing group

Other

On the basis of routine nursing, implementation of systematic SM nursing intervention for 8 weeks, the specific content is as follows: (1) The intervention group was established. (2) Baseline assessment and file establishment (within 24 hours of admission).(3) Implementation of core intervention (1st to 8th week).

Primary outcomes

  1. Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale

    Time frame: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)

    The Functional Assessment of Cancer Therapy-Lung (FACT-L) scale will be used to assess changes in quality of life in patients with advanced lung cancer. The scale consists of 36 items across five domains: physical health status, social and family conditions, emotional well-being, functional capability, and lung cancer-specific supplementary concerns. Each item is scored on a 0-4 Likert scale, with total scores ranging from 0 to 144. Higher scores indicate better quality of life. The scale has demonstrated good reliability and validity in Chinese populations (Cronbach's α = 0.88-0.92).

Secondary outcomes

  1. Change in Self-Management Efficacy as measured by the Strategies Used by People to Promote Health (SUPPH) Scale

    Time frame: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)

    The SUPPH scale will be used to assess changes in disease self-management efficacy. The scale includes 28 items across three dimensions: Positive Attitude, Self-Applied Stress Reduction, and Independent Decision-Making. Each item is scored on a 1-5 Likert scale, with total scores ranging from 28 to 140. Higher scores indicate greater self-management efficacy. The Chinese version has excellent reliability (Cronbach's α = 0.96 for the total scale).

  2. Change in Psychological Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)

    The CD-RISC will be used to assess changes in psychological resilience. The scale measures three dimensions-Tenacity, Self-Improvement, and Optimism-using 25 items. Each item is rated on a 0-4 scale, with total scores ranging from 0 to 100. Higher scores indicate stronger psychological resilience. The Chinese version has demonstrated good reliability (Cronbach's α = 0.91).

Other outcomes

  1. Mediating Effect of Self-Management Efficacy on the Relationship between Symptom Management Intervention and Quality of Life

    Time frame: Assessed at 8 weeks (post-intervention) using post-intervention scores

    This outcome will examine whether self-management efficacy (SUPPH score) mediates the relationship between the symptom management nursing intervention (group assignment) and quality of life (FACT-L score). The mediating effect will be analyzed using the PROCESS macro with bootstrap resampling (5,000 iterations). Indirect effect, direct effect, and total effect will be calculated with 95% confidence intervals. An effect is considered significant if the 95% CI does not include zero.

Sponsors and collaborators

Lead sponsor

Jie Zeng

Other Gov

Registry information

Official study title

Dahua Hospital, Xuhui District, Shanghai

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

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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