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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

25. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

176

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200031
        • Dahua Hospital, Xuhui District, Shanghai

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Annen: 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.
Annen: 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).
Annen: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Self-Management Efficacy as measured by the Strategies Used by People to Promote Health (SUPPH) Scale
Tidsramme: 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)
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mediating Effect of Self-Management Efficacy on the Relationship between Symptom Management Intervention and Quality of Life
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Jie Zeng

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. juni 2023

Primær fullføring (Faktiske)

27. oktober 2024

Studiet fullført (Faktiske)

12. desember 2025

Datoer for studieregistrering

Først innsendt

25. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 20230509

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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