Efficacy of a Self-Efficacy Nursing Model in CyberKnife-Treated Lung Cancer Patients

NCT07525908 | Completed

• 1 other identifier: 2023S00352
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether a multi-component nursing model based on self-efficacy theory can alleviate psychological distress, mitigate pain, and improve the quality of life (QoL) in lung cancer patients undergoing CyberKnife stereotactic radiosurgery compared to routine nursing care.

Conditions

Lung Neoplasms; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in General Self-Efficacy

  Change in general self-efficacy was assessed using the General Self-Efficacy Scale (GSES). The GSES is a 10-item psychometric scale where each item is rated on a 4-point Likert scale. Total scores range from 10 to 40, with higher scores indicating greater perceived self-efficacy to cope with difficulties.

  Baseline and 4 weeks

Secondary Outcomes (4)

• Change in Anxiety Level

  Baseline and 4 weeks

• Change in Pain Intensity

  Baseline and 4 weeks

• Change in Quality of Life (Physical Component Summary)

  Baseline and 4 weeks

• Change in Quality of Life (Mental Component Summary)

  Baseline and 4 weeks

Study Arms (2)

Self-Efficacy Nursing Group

EXPERIMENTAL

Patients received routine nursing care plus a structured, multi-component nursing intervention based on self-efficacy theory. The core components delivered over 4 weeks included: cognitive-behavioral education (to correct misconceptions and set realistic goals), psychological support (active listening and guided relaxation), role-model encouragement (sharing experiences of successful patients), functional exercise guidance (gentle breathing and physical activity), reinforcement of social support systems, and self-management skill training (symptom monitoring and action plans).

Behavioral: Self-Efficacy Theory-Based Nursing Model

Control Group

ACTIVE COMPARATOR

Patients received standard medical care and routine nursing care. This included standard pre-treatment education regarding the CyberKnife procedure, basic symptom monitoring and management, general psychological support during routine interactions, and standard discharge planning.

Behavioral: Routine Nursing Care

Interventions

Self-Efficacy Theory-Based Nursing Model BEHAVIORAL

Patients received routine nursing care plus a structured, multi-component nursing intervention based on self-efficacy theory. The core components delivered over 4 weeks included: cognitive-behavioral education (to correct misconceptions and set realistic goals), psychological support (active listening and guided relaxation), role-model encouragement (sharing experiences of successful patients), functional exercise guidance (gentle breathing and physical activity), reinforcement of social support systems, and self-management skill training (symptom monitoring and action plans).

Self-Efficacy Nursing Group

Routine Nursing Care BEHAVIORAL

Patients received standard medical care and routine nursing care. This included standard pre-treatment education regarding the CyberKnife procedure, basic symptom monitoring and management, general psychological support during routine interactions, and standard discharge planning.

Control Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 40 and 80 years, inclusive.
• Histologically or cytologically confirmed diagnosis of primary lung cancer (suitable for CyberKnife treatment).
• Scheduled to receive CyberKnife stereotactic radiosurgery as a primary or palliative treatment.
• Karnofsky Performance Status (KPS) score of 80-100.
• Patient-Generated Subjective Global Assessment (PG-SGA) score ≤ 5.
• Estimated life expectancy of at least 6 months.
• Able to understand, speak, and read Mandarin Chinese.
• Willing and able to provide written informed consent.

You may not qualify if:

• Presence of severe, uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases.
• Known history of severe psychiatric disorders or cognitive impairment.
• Presence of other active malignancies requiring systemic treatment.
• Known severe, uncontrolled endocrine or metabolic diseases.
• Significant coagulation disorders.
• Previous radiotherapy to the planned CyberKnife treatment field.
• Participation in another interventional clinical trial concurrently or within 30 days prior to enrollment.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

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: April 6, 2026
• First Posted: April 13, 2026
• Study Start: October 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)