NCT07049250

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable lung-cancer

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

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 25, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

ChemotherapyPsychological ResilienceIllness PerceptionEvidence-Based NursingQuantitative Evaluation Strategy

Outcome Measures

Primary Outcomes (1)

  • Change in Psychological Resilience Score

    Psychological resilience assessed using the 25-item Resilience Scale. Scores range from 0 to 100, with higher scores indicating better psychological resilience. The scale measures optimism, resilience, and strength subdomains.

    Baseline and 3 months post-intervention.

Secondary Outcomes (3)

  • Change in Illness Perception

    Baseline and 3 months post-intervention.

  • Change in Coping Styles

    Baseline and 3 months post-intervention.

  • Incidence of Chemotherapy-Related Complications

    Assessed throughout the 3-month post-intervention period.

Study Arms (2)

Evidence-Based Nursing Intervention Group

EXPERIMENTAL

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.

Behavioral: Evidence-Based Nursing Intervention under Quantitative Evaluation Strategy

Routine Nursing Care Group

ACTIVE COMPARATOR

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.

Behavioral: Routine Nursing Care

Interventions

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.

Evidence-Based Nursing Intervention Group

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.

Routine Nursing Care Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 3, 2025

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations