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

April 6, 2026 updated by: Yusha Yan, The First Hospital of Hebei Medical University

Clinical Study on the Impact of a Self-Efficacy Theory-Based Nursing Model on Psychological Distress, Pain Level, and Quality of Life in Lung Cancer Patients Treated With CyberKnife

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lung cancer patients undergoing CyberKnife stereotactic radiosurgery often experience significant psychological distress, including profound fear and anxiety, as well as pain, which negatively impacts their quality of life. This single-center, prospective, randomized controlled trial investigated a structured nursing intervention based on Albert Bandura's self-efficacy theory. A total of 300 lung cancer patients scheduled for CyberKnife treatment were randomly assigned (1:1 ratio) to an intervention group or a control group. The control group received standard medical and routine nursing care. The intervention group received a multi-component nursing model in addition to routine care. The intervention included cognitive-behavioral strategies, psychological support, role model encouragement, functional exercise guidance, social support system enhancement, and self-management training, which was initiated upon admission and continued for 4 weeks. The primary hypothesis is that this theory-based approach will significantly improve general self-efficacy, reduce symptom burden (anxiety and pain), and enhance overall quality of life compared to standard care.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • First Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Efficacy Nursing Group
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
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).
Active Comparator: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in General Self-Efficacy
Time Frame: Baseline and 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Level
Time Frame: Baseline and 4 weeks
Change in anxiety level was measured using the Zung Self-Rating Anxiety Scale (SAS). The SAS is a 20-item self-report questionnaire with a standardized index score ranging from 25 to 100. Higher scores indicate greater anxiety levels.
Baseline and 4 weeks
Change in Pain Intensity
Time Frame: Baseline and 4 weeks
Change in pain intensity was measured using a 10cm Visual Analogue Scale (VAS). Scores range from 0 ("no pain") to 10 ("worst imaginable pain").
Baseline and 4 weeks
Change in Quality of Life (Physical Component Summary)
Time Frame: Baseline and 4 weeks
Change in the Physical Component Summary (PCS) of the Short Form-36 Health Survey (SF-36). Scores are transformed to a 0-100 scale, with higher scores indicating better physical health-related quality of life.
Baseline and 4 weeks
Change in Quality of Life (Mental Component Summary)
Time Frame: Baseline and 4 weeks
Change in the Mental Component Summary (MCS) of the Short Form-36 Health Survey (SF-36). Scores are transformed to a 0-100 scale, with higher scores indicating better mental health-related quality of life.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Hebei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023S00352

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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