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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

2026年6月25日 更新者：Jie Zeng

Dahua Hospital, Xuhui District, Shanghai

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

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

176

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200031
        • Dahua Hospital, Xuhui District, Shanghai

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：Routine nursing group
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.
他の：routine nursing group
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.
他の：standardized systematic SM nursing group
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).
他の：standardized systematic SM nursing group
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).

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale
時間枠：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).
Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Self-Management Efficacy as measured by the Strategies Used by People to Promote Health (SUPPH) Scale
時間枠：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).
Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
Change in Psychological Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC)
時間枠：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).
Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)

その他の成果指標

結果測定
メジャーの説明
時間枠
Mediating Effect of Self-Management Efficacy on the Relationship between Symptom Management Intervention and Quality of Life
時間枠：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.
Assessed at 8 weeks (post-intervention) using post-intervention scores

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Jie Zeng

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年6月10日

一次修了 (実際)

2024年10月27日

研究の完了 (実際)

2025年12月12日

試験登録日

最初に提出

2026年6月25日

QC基準を満たした最初の提出物

2026年6月25日

最初の投稿 (実際)

2026年7月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月1日

QC基準を満たした最後の更新が送信されました

2026年6月25日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 20230509

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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