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NCT Number: NCT07525908

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

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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").

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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