NCT07679165

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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)

Secondary Outcomes (2)

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

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

Other Outcomes (1)

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

    Assessed at 8 weeks (post-intervention) using post-intervention scores

Study Arms (2)

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.

Other: routine nursing group

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).

Other: standardized systematic SM nursing group

Interventions

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.

Routine 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).

standardized systematic SM nursing group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dahua Hospital, Xuhui District, Shanghai

Shanghai, Shanghai Municipality, 200031, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dahua Hospital, Xuhui District, Shanghai

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

June 10, 2023

Primary Completion

October 27, 2024

Study Completion

December 12, 2025

Last Updated

July 1, 2026

Record last verified: 2026-06

Locations